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Intravitreal Ranibizumab for Vitreous Hemorrhage Due to Proliferative Diabetic Retinopathy (N)

Sponsor
Jaeb Center for Health Research (Other)
Overall Status
Completed
CT.gov ID
NCT00996437
Collaborator
National Eye Institute (NEI) (NIH)
261
Enrollment
67
Locations
2
Arms
31
Duration (Months)
3.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is being conducted to determine if intravitreal injections of ranibizumab decrease the proportion of eyes in which vitrectomy is performed compared with saline injections in eyes presenting with vitreous hemorrhage from proliferative diabetic retinopathy.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Detailed Description

In mild to moderate cases of vitreous hemorrhage, panretinal photocoagulation (PRP) is performed when possible to achieve regression of new vessels or at least stabilization of the neovascularization with no further growth in order to decrease the probability of subsequent vitreous hemorrhage while spontaneous absorption of the hemorrhage occurs. In cases in which the hemorrhage is too dense to apply PRP, vitrectomy is considered to remove the hemorrhage and provide a clear media for application of PRP (often as endolaser photocoagulation) as well as eliminate extensive neovascularization and relieve traction retinal detachments. Pars plana vitrectomy was introduced in the 1970s as a surgical intervention in diabetes for non-clearing vitreous hemorrhage, traction retinal detachment or very severe proliferative diabetic retinopathy (PDR). The goal of vitrectomy in such eyes is to remove the hemorrhage and provide a clear media for application of PRP (often as endolaser photocoagulation) as well as eliminate extensive neovascularization and relieve traction retinal detachments. Many advances in instrumentation and technique have resulted in a dramatic reduction in complications over the last few decades, but surgical complications remain including the following: neovascular glaucoma, retinal detachment, fibrinoid syndrome, endophthalmitis and hypotony with subsequent phthisis bulbi. Recovery for the subject can take up to 6 weeks.

Increased vascular endothelial growth factor (VEGF) levels have been demonstrated in the retina and vitreous of human eyes with diabetic retinopathy, especially PDR. VEGF has been demonstrated to increase vessel permeability by increasing the phosphorylation of tight junction proteins, and has been shown to increase retinal vascular permeability in in vivo models. Anti-VEGF therapy, therefore, may represent a useful therapeutic modality which targets the underlying pathogenesis of PDR while vitreous hemorrhage clears to facilitate the placement of PRP, potentially avoiding vitrectomy.

This study is designed to determine if intravitreal injections of ranibizumab will facilitate clearing of vitreous hemorrhage and avoidance of vitrectomy and its potential complications. Compared with a surgical intervention, use of an intravitreal agent associated with fewer vitrectomies would be preferable because of the reduced costs, reduced time to treatment, reduced intervention time, relatively low risk of side effects, and reduced recovery time. An intravitreal agent also would be a useful alternative for patients who are unwilling to undergo surgery. Furthermore, the study will determine the safety of this medication in the setting of PDR.

Study Design

Study Type:
Interventional
Actual Enrollment :
261 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
An Evaluation of Intravitreal Ranibizumab for Vitreous Hemorrhage Due to Proliferative Diabetic Retinopathy
Study Start Date :
Jun 1, 2010
Actual Primary Completion Date :
Feb 1, 2012
Actual Study Completion Date :
Jan 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Saline Injection

Saline injection at baseline, 4 and 8 weeks

Drug: Saline
Saline injection of 0.5mg at baseline, 4 and 8 weeks
Active Comparator: Ranibizumab

Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks

Drug: Ranibizumab
Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
Other Names:
  • Lucentis

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Treatment or "Failure" Defined as Vitrectomy [within 112 days of randomization]

      The cumulative probabilities of vitrectomy by 16 weks (112 days) in each group were computed using the life-table method. The treatment group comparison was made using the log-rank test. Data were censored at the time point of the participant's last completed visit.

    2. Safety (Injected-related, Ocular Drug-related and Systemic Drug-related) [Baseline to 16 weeks]

    Secondary Outcome Measures

    1. Ability to Complete Panretinal Photocoagulation (PRP) in the Absence of Vitrectomy [within 112 days of randomization]

      The proportion of eyes with "complete" panretinal photocoagulation by 16 weeks in abscence of vitrectomy was computed using the life-table method and treatment groups were compared using the log-rank test.

    2. Extent of Vitreous Hemorrhage Measured by Optical Coherence Tomography Signal Strength [4, 8 and 12 weeks]

      Optical coherence tomography signal strength was evaluated as a potential indicator of vitreous hemorrhage density in an exploratory analysis. This analysis included only eyes with Optical Coherence Tomography (OCT) signal strength equals to 0 at baseline.

    3. Visual Acuity Adjusted for the Baseline Acuity Regardless of Vitrectomy Status [4, 8 and 12 weeks]

      Visual acuity was analyzed using a longitudinal mixed regression model adjusting for baseline visual acuity.Unit of measure is based on the E-ETDRS visual acuity letter score scale, 0-97, where 0 = worst and 97 = best.

    4. Visual Acuity Better Than 20/40 and no Vitrectomy Prior to the Visit [4, 8 and 12 weeks]

    5. Severe Visual Acuity Loss (Defined as <20/200) [4,8 and 12 weeks]

    6. Very Severe Visual Acuity Loss (Defined as <20/800) [4,8 and 12 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Subject-level Criteria

    Inclusion

    To be eligible, the following inclusion criteria must be met:

    Age >= 18 years Diagnosis of diabetes mellitus (type 1 or type 2) At least one eye meets the study eye criteria listed below Able and willing to provide informed consent.

    Exclusion

    A subject is not eligible if any of the following exclusion criteria are present:

    A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).

    A condition that, in the opinion of the investigator, would preclude subject undergoing elective vitrectomy surgery if indicated during the study.

    Participation in an investigational trial that involved treatment with any drug within 30 days of randomization that has not received regulatory approval at the time of study entry.

    Known allergy to any component of the study drug. Blood pressure > 180/110 (systolic above 180 or diastolic above 110). Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization.

    Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization.

    For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 4 months.

    Subject is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the 12 months of the study.

    Study Eye Criteria

    The subject must have at least one eye meeting all of the inclusion criteria and none of the exclusion criteria listed below.

    A subject can have only one study eye. If both eyes are eligible at the time of randomization, the study eye will be selected by the investigator and subject before randomization.

    The eligibility criteria for a study eye are as follows:

    Inclusion

    Vitreous hemorrhage causing vision impairment, presumed to be from proliferative diabetic retinopathy, and precluding completion of panretinal photocoagulation (or precluding assessment of completeness of prior PRP).

    Immediate vitrectomy not required (investigator and subject are willing to wait at least 8 weeks to see if hemorrhage clears sufficiently without having to proceed to vitrectomy).

    Visual acuity is light perception or better.

    Exclusion

    Prompt vitrectomy indicated, such as because of signs of rhegmatogenous retinal detachment or traction detachment involving the macula present on ultrasound.

    Exam evidence of neovascular glaucoma, angle neovascularization, or active neovascularization of the iris (small iris tufts not an exclusion).

    History of intravitreal anti-VEGF treatment for vitreous hemorrhage at any time in the past or for an indication other than vitreous hemorrhage in the past 2 months.

    History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or major ocular surgery other than vitrectomy anticipated within the next 6 months following randomization.

    History of vitrectomy. History of yttrium aluminum garnet capsulotomy performed within 2 months prior to randomization.

    Aphakia. Uncontrolled glaucoma (in investigator's judgment). Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Retinal Consultants of AZ Phoenix Arizona United States 85014
    2 University of California, Irvine Irvine California United States 92697
    3 Loma Linda University Health Care, Dept. of Ophthalmology Loma Linda California United States 92354
    4 Southern California Desert Retina Consultants, MC Palm Springs California United States 92262
    5 Bay Area Retina Associates Walnut Creek California United States 94598
    6 Retinal Consultants of Southern California Medical Group, Inc. Westlake Village California United States 91361
    7 Denver Health Medical Center Denver Colorado United States 80204
    8 New England Retina Associates, PC Trumbull Connecticut United States 06611
    9 The George Washington University, Department of Ophthalmology Washington District of Columbia United States 20037
    10 Retina Consultants of Southwest Florida Fort Myers Florida United States 33912
    11 University of Florida College of Med., Department of Ophthalmology Jacksonville Florida United States 32209
    12 Florida Retina Consultants Lakeland Florida United States 33805
    13 Magruder Eye Institute Orlando Florida United States 32803
    14 Sarasota Retina Institute Sarasota Florida United States 34239
    15 Retina Associates of Sarasota Venice Florida United States 34285
    16 Emory Eye Center Atlanta Georgia United States 30322
    17 Georgia Retina, P.C. Atlanta Georgia United States 30342
    18 Southeast Retina Center, P.C. Augusta Georgia United States 30909
    19 Retina Associates of Hawaii, Inc. Honolulu Hawaii United States 96813
    20 University of Illinois at Chicago Medical Center Chicago Illinois United States 60612
    21 Raj K. Maturi, M.D., P.C. Indianapolis Indiana United States 46290
    22 American Eye Institute New Albany Indiana United States 47150
    23 Medical Associates Clinic, P.C. Dubuque Iowa United States 52002
    24 Wolfe Eye Clinic West Des Moines Iowa United States 50266
    25 Sabates Eye Centers Research Division Leawood Kansas United States 66211
    26 Retina and Vitreous Associates of Kentucky Lexington Kentucky United States 40509-1802
    27 Paducah Retinal Center Paducah Kentucky United States 42001
    28 Elman Retina Group, P.A. Baltimore Maryland United States 21237
    29 Wilmer Eye Institute at Johns Hopkins Baltimore Maryland United States 21287-9177
    30 Wilmer Eye Institute at Johns Hopkins Baltimore Maryland United States 21287-9277
    31 Retina Consultants of Delmarva, P.A. Salisbury Maryland United States 21804
    32 Joslin Diabetes Center Boston Massachusetts United States 02215
    33 Henry Ford Health System, Dept of Ophthalmology and Eye Care Services Detroit Michigan United States 48202
    34 Vitreo-Retinal Associates Grand Rapids Michigan United States 49525
    35 Retina Center, PA Minneapolis Minnesota United States 55404
    36 Barnes Retina Institute St. Louis Missouri United States 63110
    37 Delaware Valley Retina Associates Lawrenceville New Jersey United States 08648
    38 The New York Eye and Ear Infirmary/Faculty Eye Practice New York New York United States 10003
    39 Mount Sinai School of Medicine, Dept. of Ophthalmology New York New York United States 10029
    40 Retina Consultants of Western New York Orchard Park New York United States 14127
    41 Eye Care for the Adirondacks Plattsburgh New York United States 12901
    42 Retina-Vitreous Surgeons of Central New York, PC Syracuse New York United States 13224
    43 University of North Carolina, Dept of Ophthalmology Chapel Hill North Carolina United States 27599-7040
    44 Charlotte Eye Ear Nose and Throat Assoc, PA Charlotte North Carolina United States 28210
    45 Piedmont Retina Specialists, PA Greensboro North Carolina United States 27401
    46 Mid-America Retina Consultants, P.A. Kansas City North Carolina United States 64111
    47 Wake Forest University Eye Center Winston-Salem North Carolina United States 27157
    48 Retina Associates of Cleveland, Inc. Beachwood Ohio United States 44122
    49 Case Western Reserve University Cleveland Ohio United States 44106
    50 OSU Eye Physicians and Surgeons, LLC. Columbus Ohio United States 43212
    51 Retina Northwest, PC Portland Oregon United States 97210
    52 Family Eye Group Lancaster Pennsylvania United States 17601-2644
    53 University of Pennsylvania Scheie Eye Institute Philadelphia Pennsylvania United States 19104
    54 Carolina Retina Center Columbia South Carolina United States 29223
    55 Southeastern Retina Associates, PC Kingsport Tennessee United States 37660
    56 Southeastern Retina Associates, P.C. Knoxville Tennessee United States 37909
    57 West Texas Retina Consultants P.A. Abilene Texas United States 79605
    58 Retina Research Center Austin Texas United States 78705
    59 Retina and Vitreous of Texas Houston Texas United States 77025
    60 Baylor Eye Physicians and Surgeons Houston Texas United States 77030
    61 Texas Retina Associates Lubbock Texas United States 79424
    62 Valley Retina Institute McAllen Texas United States 78503
    63 Medical Center Ophthalmology Associates San Antonio Texas United States 78240
    64 Retinal Consultants of San Antonio San Antonio Texas United States 78240
    65 Virginia Retina Center Leesburg Virginia United States 20176
    66 University of Washington Medical Center Seattle Washington United States 98195
    67 Medical College of Wiconsin Milwaukee Wisconsin United States 53226

    Sponsors and Collaborators

    • Jaeb Center for Health Research
    • National Eye Institute (NEI)

    Investigators

    • Study Director: Adam R. Glassman, MS, Jaeb Center for Health Research
    • Study Chair: Abdhish Bhavsar, MD, Retina Center, PA

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Jaeb Center for Health Research
    ClinicalTrials.gov Identifier:
    NCT00996437
    Other Study ID Numbers:
    • NEI-151
    • U10EY018817-03
    • U10EY014231-09
    First Posted:
    Oct 16, 2009
    Last Update Posted:
    Aug 26, 2016
    Last Verified:
    Aug 1, 2016
    Keywords provided by Jaeb Center for Health Research
    vitreous
    hemorrhage
    proliferative
    diabetic
    retinopathy
    intravitreal
    ranibizumab
    Lucentis
    saline
    vitrectomy
    Additional relevant MeSH terms:
    Retinal Diseases
    Diabetic Retinopathy
    Vitreous Hemorrhage
    Hemorrhage
    Ranibizumab

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Ranibizumab Saline Injection
    Arm/Group Description Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
    Period Title: Overall Study
    STARTED 125 136
    COMPLETED 120 129
    NOT COMPLETED 5 7

    Baseline Characteristics

    Arm/Group Title Ranibizumab Saline Injection Total
    Arm/Group Description Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks Total of all reporting groups
    Overall Participants 125 136 261
    Age, Customized (years) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [years]
    61
    58
    59
    Sex: Female, Male (Count of Participants)
    Female
    65
    52%
    70
    51.5%
    135
    51.7%
    Male
    60
    48%
    66
    48.5%
    126
    48.3%
    Race/Ethnicity, Customized (participants) [Number]
    White
    67
    53.6%
    70
    51.5%
    137
    52.5%
    African-American
    20
    16%
    22
    16.2%
    42
    16.1%
    Hispanic or Latino
    32
    25.6%
    34
    25%
    66
    25.3%
    Asian
    1
    0.8%
    4
    2.9%
    5
    1.9%
    Native Hawaiian/Other Pacific Islander
    2
    1.6%
    1
    0.7%
    3
    1.1%
    American Indian/Alaskan Native
    0
    0%
    2
    1.5%
    2
    0.8%
    More than one race
    2
    1.6%
    1
    0.7%
    3
    1.1%
    Unknown/not reported
    1
    0.8%
    2
    1.5%
    3
    1.1%
    Diabetes Type (Number) [Number]
    Type1
    21
    16.8%
    31
    22.8%
    52
    19.9%
    Type 2
    101
    80.8%
    99
    72.8%
    200
    76.6%
    Uncertain
    3
    2.4%
    6
    4.4%
    9
    3.4%
    Duration of Diabetes (years) (Number) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [Number]
    19
    21
    20
    Hemoglobin A1c (Percentage) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [Percentage]
    7.7
    8.0
    7.9
    Pre-Existing Cardiovascular Conditions (Number) [Number]
    Yes
    44
    35.2%
    60
    44.1%
    104
    39.8%
    No
    81
    64.8%
    76
    55.9%
    157
    60.2%
    Pre-Existing Hypertension (Number) [Number]
    Yes
    105
    84%
    117
    86%
    222
    85.1%
    No
    20
    16%
    19
    14%
    39
    14.9%
    Prior panretinal photocoagulation (Number) [Number]
    Yes
    62
    49.6%
    78
    57.4%
    140
    53.6%
    No
    63
    50.4%
    58
    42.6%
    121
    46.4%
    Prior Treatment for Diabetic Macular Edema (Number) [Number]
    Yes
    53
    42.4%
    57
    41.9%
    110
    42.1%
    No
    72
    57.6%
    79
    58.1%
    151
    57.9%
    Prior treatment with anti-vascular endothelial growth factor drug for diabetic macular edema (Number) [Number]
    Yes
    10
    8%
    18
    13.2%
    28
    10.7%
    No
    115
    92%
    118
    86.8%
    233
    89.3%
    Lens Status (on clinical exam) (Number) [Number]
    Phakic
    97
    77.6%
    98
    72.1%
    195
    74.7%
    Posterior Chamber Intraocular Lens
    28
    22.4%
    38
    27.9%
    66
    25.3%
    Optical coherence tomography signal strength (Number) [Number]
    =0
    74
    59.2%
    96
    70.6%
    170
    65.1%
    > 0
    50
    40%
    38
    27.9%
    88
    33.7%
    Missing/not available
    1
    0.8%
    2
    1.5%
    3
    1.1%
    Ultrasound completed to assess eligibility (Number) [Number]
    Yes
    62
    49.6%
    62
    45.6%
    124
    47.5%
    No
    63
    50.4%
    74
    54.4%
    137
    52.5%
    Duration of vitreous hemorrhage since first documented on clinical exam (Number) [Number]
    < 1month
    66
    52.8%
    75
    55.1%
    141
    54%
    1-3 months
    41
    32.8%
    39
    28.7%
    80
    30.7%
    4-6 months
    7
    5.6%
    11
    8.1%
    18
    6.9%
    > 6 months
    11
    8.8%
    11
    8.1%
    22
    8.4%
    Median Electronic-Early Treatment Diabetic Retinopathy Visual Acuity (letter score) (Units on a scale) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [Units on a scale]
    34
    28
    31
    Electronic Early Treatment Diabetic Retinopathy Visual Acuity Score (Number) [Number]
    > 69 letter score - (20/40 or better)
    20
    16%
    21
    15.4%
    41
    15.7%
    68 to 49 letter score - (20/50 to 20/100)
    32
    25.6%
    19
    14%
    51
    19.5%
    48 to 24 letter score - (20/125 to 20/320)
    18
    14.4%
    37
    27.2%
    55
    21.1%
    23 to 1 letter score - (20/400 to 20/800-3)
    19
    15.2%
    18
    13.2%
    37
    14.2%
    Counting fingers only
    12
    9.6%
    15
    11%
    27
    10.3%
    Hand motion only
    19
    15.2%
    20
    14.7%
    39
    14.9%
    Light perception only
    5
    4%
    6
    4.4%
    11
    4.2%
    No light perception
    0
    0%
    0
    0%
    0
    0%
    Intraocular Pressure (mm Hg) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [mm Hg]
    15
    14
    15
    Anti-platelet aggregation and anti-coagulant drugs (Number) [Number]
    Aspirin
    50
    40%
    57
    41.9%
    107
    41%
    Other anti-platelet aggregation drugs
    19
    15.2%
    21
    15.4%
    40
    15.3%
    Anti-coagulants
    7
    5.6%
    6
    4.4%
    13
    5%
    NSAIDs
    15
    12%
    15
    11%
    30
    11.5%
    Not Available
    34
    27.2%
    37
    27.2%
    71
    27.2%

    Outcome Measures

    1. Primary Outcome
    Title Treatment or "Failure" Defined as Vitrectomy
    Description The cumulative probabilities of vitrectomy by 16 weks (112 days) in each group were computed using the life-table method. The treatment group comparison was made using the log-rank test. Data were censored at the time point of the participant's last completed visit.
    Time Frame within 112 days of randomization

    Outcome Measure Data

    Analysis Population Description
    The primary analysis followed the intent-to-treat principle and included all randomized eyes.
    Arm/Group Title Ranibizumab Saline Injection
    Arm/Group Description Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
    Measure Participants 125 136
    Number [percentage of participants]
    12
    9.6%
    17
    12.5%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ranibizumab, Saline Injection
    Comments The cumulative probabilities of vitrectomy by 16 weeks in each group were computed using the life-table method. Treatment group comparisons were performed using the log-rank test. The treatment difference in cumulative probabilities and 95% confidence interval were reported.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.37
    Comments
    Method Log Rank
    Comments After adjusting for potential confounding factors, time to vitrectomy remained similar between treatment groups.
    Method of Estimation Estimation Parameter Treatment Difference in Cumulative Prob
    Estimated Value 4
    Confidence Interval (2-Sided) 95%
    -4 to 13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Primary Outcome
    Title Safety (Injected-related, Ocular Drug-related and Systemic Drug-related)
    Description
    Time Frame Baseline to 16 weeks

    Outcome Measure Data

    Analysis Population Description
    Adverse events for each participants was collected throughout study duration.
    Arm/Group Title Ranibizumab Saline Injection
    Arm/Group Description Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
    Measure Participants 125 136
    Endophthalmitis
    0
    0%
    1
    0.7%
    Traction and/or rhegmatogeneous retinal detachment
    10
    8%
    11
    8.1%
    Angle or iris neovascularization
    1
    0.8%
    4
    2.9%
    Neovascular glaucoma
    1
    0.8%
    1
    0.7%
    Cataract Surgery
    0
    0%
    2
    1.5%
    Recurrent vitreous hemorrhage on clinical exam
    8
    6.4%
    23
    16.9%
    Elevated Intraocular Pressure (IOP)/Glaucoma
    16
    12.8%
    19
    14%
    Increase of IOP >= 10 mm Hg from baseline
    8
    6.4%
    11
    8.1%
    IOP >= 30 mm Hg
    4
    3.2%
    4
    2.9%
    Currently on IOP-lowering medication, not baseline
    13
    10.4%
    14
    10.3%
    Glaucoma surgery at anytime
    0
    0%
    0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ranibizumab, Saline Injection
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.01
    Comments P-value corresponds with recurrent vitreous hemorrhage evaluated on clinical exam between the two treatment arms.
    Method Fisher Exact
    Comments
    3. Secondary Outcome
    Title Ability to Complete Panretinal Photocoagulation (PRP) in the Absence of Vitrectomy
    Description The proportion of eyes with "complete" panretinal photocoagulation by 16 weeks in abscence of vitrectomy was computed using the life-table method and treatment groups were compared using the log-rank test.
    Time Frame within 112 days of randomization

    Outcome Measure Data

    Analysis Population Description
    The secondary analysis followed the intent-to-treat principle and included all randomized eyes.
    Arm/Group Title Ranibizumab Saline Injection
    Arm/Group Description Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
    Measure Participants 125 136
    Number [percentage of eyes]
    44
    31
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ranibizumab, Saline Injection
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.05
    Comments
    Method Log Rank
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.54
    Confidence Interval (2-Sided) 95%
    1.03 to 2.30
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    Title Extent of Vitreous Hemorrhage Measured by Optical Coherence Tomography Signal Strength
    Description Optical coherence tomography signal strength was evaluated as a potential indicator of vitreous hemorrhage density in an exploratory analysis. This analysis included only eyes with Optical Coherence Tomography (OCT) signal strength equals to 0 at baseline.
    Time Frame 4, 8 and 12 weeks

    Outcome Measure Data

    Analysis Population Description
    This analysis followed the intent-to-treat principle
    Arm/Group Title Ranibizumab Saline Injection
    Arm/Group Description Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
    Measure Participants 125 136
    4 week results
    40
    28
    8 week results
    46
    38
    12 week results
    51
    52
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ranibizumab, Saline Injection
    Comments Signal strength was analyzed as a composite outcome defined as OCT signal strength > = and no vitrectomy vs. OCT signal strength = 0.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.87
    Comments P-value corresponds to the 12 week visit treatment comparison.
    Method GLM with GEE method
    Comments Number of subjects with baseline OCT ss=0 and OCT ss>0 and no vitrectomy at follow up. A generalized GLM with GEE was used for treatment comparisons.
    5. Secondary Outcome
    Title Visual Acuity Adjusted for the Baseline Acuity Regardless of Vitrectomy Status
    Description Visual acuity was analyzed using a longitudinal mixed regression model adjusting for baseline visual acuity.Unit of measure is based on the E-ETDRS visual acuity letter score scale, 0-97, where 0 = worst and 97 = best.
    Time Frame 4, 8 and 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Number of participants with a complete 4 week visit, 8 and 12 week respectively and an available visual acuity measurement.
    Arm/Group Title Ranibizumab Saline Injection
    Arm/Group Description Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
    Measure Participants 125 136
    4 week results
    45
    (30)
    42
    (31)
    8 week results
    51
    (30)
    47
    (31)
    12 week results
    57
    (27)
    49
    (29)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ranibizumab, Saline Injection
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value .04
    Comments P-value corresponds to the 12 week visit treatment comparison.
    Method Mixed Models Analysis
    Comments Treatment comparisons were performed using a longitudinal mixed model adjusting for baseline visual acuity.
    6. Secondary Outcome
    Title Visual Acuity Better Than 20/40 and no Vitrectomy Prior to the Visit
    Description
    Time Frame 4, 8 and 12 weeks

    Outcome Measure Data

    Analysis Population Description
    This analysis followed the intent-to-treat principle. It includes all randomized eyes with a completed 4, 8 and 12 week visit respectively and an available visual acuity measure.
    Arm/Group Title Ranibizumab Saline Injection
    Arm/Group Description Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
    Measure Participants 125 136
    4 week results
    29
    23.2%
    29
    21.3%
    8 week results
    36
    28.8%
    33
    24.3%
    12 week results
    45
    36%
    33
    24.3%
    7. Secondary Outcome
    Title Severe Visual Acuity Loss (Defined as <20/200)
    Description
    Time Frame 4,8 and 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Participant with a completed 4,8 and 12 week visit and an available visual acuity measurement were included in this analysis.
    Arm/Group Title Ranibizumab Saline Injection
    Arm/Group Description Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
    Measure Participants 125 136
    4 week results
    38
    30.4%
    38
    27.9%
    8 week results
    30
    24%
    35
    25.7%
    12 week results
    20
    16%
    27
    19.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ranibizumab, Saline Injection
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value .023
    Comments P-value corresponds with the 12 week visit treatment comparison
    Method Fisher Exact
    Comments At the each time point, treatment comparison analysis was performed using a Fisher Exact test.
    8. Secondary Outcome
    Title Very Severe Visual Acuity Loss (Defined as <20/800)
    Description
    Time Frame 4,8 and 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants with a completed 4, 8 and 12 week visit respectively and an available visual acuity measurement were included in the analysis.
    Arm/Group Title Ranibizumab Saline Injection
    Arm/Group Description Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
    Measure Participants 125 136
    4 week results
    20
    16%
    25
    18.4%
    8 week results
    16
    12.8%
    19
    14%
    12 week results
    11
    8.8%
    16
    11.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ranibizumab
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.27
    Comments
    Method Fisher Exact
    Comments At each time point, treatment comparison analysis was performed using a Fisher Exact Test.

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Ranibizumab Saline Injection
    Arm/Group Description Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
    All Cause Mortality
    Ranibizumab Saline Injection
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Ranibizumab Saline Injection
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 13/125 (10.4%) 23/136 (16.9%)
    Cardiac disorders
    Angina pectoris 0/125 (0%) 0 1/136 (0.7%) 1
    Congestive cardiac failure 0/125 (0%) 0 1/136 (0.7%) 1
    Cardiomegaly 1/125 (0.8%) 1 0/136 (0%) 0
    Myocardial Infarction 0/125 (0%) 0 1/136 (0.7%) 1
    Endocrine disorders
    Diabetic gastroparesis 0/125 (0%) 0 1/136 (0.7%) 1
    Hypoglycaemia 0/125 (0%) 0 2/136 (1.5%) 2
    Eye disorders
    Endophthalmitis 0/125 (0%) 0 1/136 (0.7%) 1
    Retinal detachment 3/125 (2.4%) 3 4/136 (2.9%) 5
    Glaucoma 1/125 (0.8%) 1 0/136 (0%) 0
    Retinal Tear 0/125 (0%) 0 1/136 (0.7%) 1
    Visual acuity reduced 0/125 (0%) 0 1/136 (0.7%) 1
    Gastrointestinal disorders
    Abdominal Pain 1/125 (0.8%) 1 0/136 (0%) 0
    Appendicitis 0/125 (0%) 0 1/136 (0.7%) 1
    Vomiting 0/125 (0%) 0 1/136 (0.7%) 1
    General disorders
    Chest pain 1/125 (0.8%) 1 0/136 (0%) 0
    Death 1/125 (0.8%) 1 0/136 (0%) 0
    Infections and infestations
    Bronchopneumonia 0/125 (0%) 0 1/136 (0.7%) 1
    Gastroenteritis 0/125 (0%) 0 1/136 (0.7%) 1
    Herpes Zoster 0/125 (0%) 0 1/136 (0.7%) 1
    Osteomyelitis 1/125 (0.8%) 1 0/136 (0%) 0
    Pneumonia 0/125 (0%) 0 1/136 (0.7%) 1
    Metabolism and nutrition disorders
    Hyperkalaemia 0/125 (0%) 0 1/136 (0.7%) 1
    Musculoskeletal and connective tissue disorders
    Back Pain 1/125 (0.8%) 1 0/136 (0%) 0
    Upper limb fracture 0/125 (0%) 0 1/136 (0.7%) 1
    Psychiatric disorders
    Depression 0/125 (0%) 0 1/136 (0.7%) 1
    Renal and urinary disorders
    Haematuria 0/125 (0%) 0 1/136 (0.7%) 1
    Renal Faliure 0/125 (0%) 0 2/136 (1.5%) 2
    Renal Failure Acute 0/125 (0%) 0 1/136 (0.7%) 1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 1/125 (0.8%) 1 0/136 (0%) 0
    Hypoxia 0/125 (0%) 0 1/136 (0.7%) 1
    Respiratory distress 1/125 (0.8%) 1 0/136 (0%) 0
    Skin and subcutaneous tissue disorders
    Cellulitis 1/125 (0.8%) 1 1/136 (0.7%) 1
    Skin Ulcer 1/125 (0.8%) 1 0/136 (0%) 0
    Vascular disorders
    Diabetic foot 1/125 (0.8%) 1 0/136 (0%) 0
    Hypertension 0/125 (0%) 0 3/136 (2.2%) 3
    Intermittent claudication 0/125 (0%) 0 1/136 (0.7%) 1
    Peripheral vascular disorder 0/125 (0%) 0 1/136 (0.7%) 1
    Transient ishaemic attack 1/125 (0.8%) 1 1/136 (0.7%) 1
    Other (Not Including Serious) Adverse Events
    Ranibizumab Saline Injection
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 84/125 (67.2%) 94/136 (69.1%)
    Blood and lymphatic system disorders
    Anaemia 2/125 (1.6%) 2 3/136 (2.2%) 3
    Anaemia of chronic disease 1/125 (0.8%) 1 0/136 (0%) 0
    Leukocytosis 2/125 (1.6%) 2 0/136 (0%) 0
    Cardiac disorders
    Atrial fibrilliation 1/125 (0.8%) 1 0/136 (0%) 0
    Cardiomegaly 1/125 (0.8%) 1 1/136 (0.7%) 1
    Ear and labyrinth disorders
    Otitis media acute 1/125 (0.8%) 1 0/136 (0%) 0
    Endocrine disorders
    Diabetes mellitus inadequate control 1/125 (0.8%) 1 1/136 (0.7%) 1
    Hyperglycaemia 1/125 (0.8%) 1 0/136 (0%) 0
    Hypoglycaemia 0/125 (0%) 0 3/136 (2.2%) 3
    Hypthyroidism 0/125 (0%) 0 1/136 (0.7%) 1
    Eye disorders
    Anterior chamber cell 1/125 (0.8%) 1 0/136 (0%) 0
    Anterior chamber flare 1/125 (0.8%) 1 0/136 (0%) 0
    Aphkia 0/125 (0%) 0 1/136 (0.7%) 1
    Blepharitis 1/125 (0.8%) 1 0/136 (0%) 0
    Borderline glaucoma 1/125 (0.8%) 1 2/136 (1.5%) 2
    Cataract 5/125 (4%) 5 7/136 (5.1%) 7
    Cataract cortical 1/125 (0.8%) 1 1/136 (0.7%) 1
    Cataract nuclear 2/125 (1.6%) 3 0/136 (0%) 0
    Cataract operation complication 1/125 (0.8%) 1 0/136 (0%) 0
    Cataract subcapsular 2/125 (1.6%) 2 3/136 (2.2%) 3
    Choroidal detachment 0/125 (0%) 0 1/136 (0.7%) 1
    Conjunctival hemorrhage 7/125 (5.6%) 11 7/136 (5.1%) 10
    Conjunctival hyperaemia 0/125 (0%) 0 2/136 (1.5%) 3
    Conjunctivitis 0/125 (0%) 0 1/136 (0.7%) 1
    Corneal abrasion 2/125 (1.6%) 3 1/136 (0.7%) 1
    Corneal defect 0/125 (0%) 0 1/136 (0.7%) 1
    Diabetic retinal oedema 3/125 (2.4%) 3 3/136 (2.2%) 3
    Diabetic retinopathy 0/125 (0%) 0 1/136 (0.7%) 1
    Diplopia 1/125 (0.8%) 1 0/136 (0%) 0
    Dry eye 0/125 (0%) 0 1/136 (0.7%) 1
    Eye discharge 1/125 (0.8%) 1 0/136 (0%) 0
    Eye irritation 3/125 (2.4%) 4 3/136 (2.2%) 4
    Eye pain 14/125 (11.2%) 18 14/136 (10.3%) 15
    Eye pruritus 1/125 (0.8%) 1 3/136 (2.2%) 6
    Eyelid ptosis 0/125 (0%) 0 1/136 (0.7%) 1
    Eyelid oedema 1/125 (0.8%) 1 0/136 (0%) 0
    Foreign body sensation in eyes 3/125 (2.4%) 3 0/136 (0%) 0
    Glaucoma 2/125 (1.6%) 2 4/136 (2.9%) 4
    Hordeolum 0/125 (0%) 0 1/136 (0.7%) 1
    Hyphaema 2/125 (1.6%) 2 0/136 (0%) 0
    Iris neovascularization 0/125 (0%) 0 3/136 (2.2%) 3
    Irititis 1/125 (0.8%) 1 1/136 (0.7%) 1
    Keratitis 2/125 (1.6%) 2 0/136 (0%) 0
    Lacrimation increased 4/125 (3.2%) 4 2/136 (1.5%) 2
    Macular cyst 0/125 (0%) 0 1/136 (0.7%) 1
    Macular fibrosis 1/125 (0.8%) 1 1/136 (0.7%) 1
    Macular ischaemia 0/125 (0%) 0 1/136 (0.7%) 2
    Mascular oedema 1/125 (0.8%) 1 1/136 (0.7%) 1
    Maculopathy 5/125 (4%) 5 2/136 (1.5%) 2
    Metamorphosia 1/125 (0.8%) 1 1/136 (0.7%) 1
    Night blindness 0/125 (0%) 0 1/136 (0.7%) 2
    Ocular discomfort 2/125 (1.6%) 2 1/136 (0.7%) 1
    Ocular hyperaemia 0/125 (0%) 0 2/136 (1.5%) 2
    Ocular hypertension 1/125 (0.8%) 1 1/136 (0.7%) 1
    Optic atrophy 0/125 (0%) 0 1/136 (0.7%) 1
    Photophobia 1/125 (0.8%) 2 1/136 (0.7%) 1
    Photopsia 4/125 (3.2%) 6 3/136 (2.2%) 5
    Posterior capsule opacification 0/125 (0%) 0 1/136 (0.7%) 1
    Punctate keratitis 0/125 (0%) 0 2/136 (1.5%) 3
    Retinal aneurysm 1/125 (0.8%) 1 0/136 (0%) 0
    Retinal detachment 6/125 (4.8%) 7 7/136 (5.1%) 7
    Retinal disorder 0/125 (0%) 0 2/136 (1.5%) 2
    Retinal haemorrhage 1/125 (0.8%) 1 2/136 (1.5%) 2
    Retinal neovascularization 0/125 (0%) 0 4/136 (2.9%) 5
    Retinal tear 1/125 (0.8%) 1 1/136 (0.7%) 1
    Vision blurred 8/125 (6.4%) 10 11/136 (8.1%) 12
    Visual acuity reduced 6/125 (4.8%) 6 7/136 (5.1%) 7
    Visual field defect 1/125 (0.8%) 2 0/136 (0%) 0
    Visual impairment 5/125 (4%) 7 2/136 (1.5%) 2
    Vitreous detachment 1/125 (0.8%) 1 0/136 (0%) 0
    Vitreous disorder 1/125 (0.8%) 1 1/136 (0.7%) 1
    Vitreous floaters 14/125 (11.2%) 15 11/136 (8.1%) 14
    Vitreous hemorrhage 16/125 (12.8%) 17 20/136 (14.7%) 25
    Gastrointestinal disorders
    Abdominal discomfort 0/125 (0%) 0 1/136 (0.7%) 1
    Abdominal pain 0/125 (0%) 0 2/136 (1.5%) 2
    Diarrhoea 5/125 (4%) 5 1/136 (0.7%) 1
    Nausea 8/125 (6.4%) 10 2/136 (1.5%) 2
    Vomiting 2/125 (1.6%) 2 1/136 (0.7%) 1
    General disorders
    Chest pain 1/125 (0.8%) 1 1/136 (0.7%) 1
    Chills 0/125 (0%) 0 1/136 (0.7%) 1
    Constipation 2/125 (1.6%) 2 1/136 (0.7%) 1
    Facial pain 1/125 (0.8%) 1 0/136 (0%) 0
    Fatigue 1/125 (0.8%) 1 0/136 (0%) 0
    Oedema peripheral 0/125 (0%) 0 4/136 (2.9%) 5
    Pyrexia 1/125 (0.8%) 1 1/136 (0.7%) 2
    Hepatobiliary disorders
    Ascites 0/125 (0%) 0 1/136 (0.7%) 1
    Immune system disorders
    Hypersensitivity 0/125 (0%) 0 1/136 (0.7%) 1
    Seasonal allergy 1/125 (0.8%) 1 1/136 (0.7%) 1
    Urticaria 1/125 (0.8%) 1 1/136 (0.7%) 1
    Infections and infestations
    Bronchitis 0/125 (0%) 0 1/136 (0.7%) 1
    Cystitis 1/125 (0.8%) 1 0/136 (0%) 0
    Ear infection 0/125 (0%) 0 1/136 (0.7%) 1
    Gastroenteritis 0/125 (0%) 0 1/136 (0.7%) 1
    Herpes Zoster 1/125 (0.8%) 1 0/136 (0%) 0
    Influenza 0/125 (0%) 0 2/136 (1.5%) 2
    Localised infection 0/125 (0%) 0 1/136 (0.7%) 1
    Osteomyelitis 0/125 (0%) 0 1/136 (0.7%) 1
    Skin infection 0/125 (0%) 0 2/136 (1.5%) 2
    Upper respiratory tract infection 4/125 (3.2%) 4 3/136 (2.2%) 3
    Urinary tract infection 1/125 (0.8%) 1 1/136 (0.7%) 1
    Injury, poisoning and procedural complications
    Fall 2/125 (1.6%) 2 1/136 (0.7%) 1
    Foot fracture 1/125 (0.8%) 1 0/136 (0%) 0
    Laceration 0/125 (0%) 0 1/136 (0.7%) 1
    Upper limb fracture 1/125 (0.8%) 1 0/136 (0%) 0
    Wound 0/125 (0%) 0 1/136 (0.7%) 1
    Investigations
    Blood potasium increased 1/125 (0.8%) 1 0/136 (0%) 0
    Intra ocular pressure increased 1/125 (0.8%) 1 1/136 (0.7%) 1
    Mammogram abnormal 0/125 (0%) 0 1/136 (0.7%) 1
    Metabolism and nutrition disorders
    Hypercholesterolaemia 0/125 (0%) 0 1/136 (0.7%) 1
    Hyperlipidaemia 0/125 (0%) 0 1/136 (0.7%) 1
    Hypokalaemia 0/125 (0%) 0 1/136 (0.7%) 1
    Malnutrition 0/125 (0%) 0 1/136 (0.7%) 1
    Musculoskeletal and connective tissue disorders
    Back pain 1/125 (0.8%) 1 2/136 (1.5%) 2
    Multiple fractures 0/125 (0%) 0 1/136 (0.7%) 1
    Muscle spasm 1/125 (0.8%) 1 0/136 (0%) 0
    Neck pain 0/125 (0%) 0 3/136 (2.2%) 3
    Osteoarthritis 1/125 (0.8%) 1 0/136 (0%) 0
    Pain in extremity 0/125 (0%) 0 3/136 (2.2%) 3
    Tendonitis 1/125 (0.8%) 1 0/136 (0%) 0
    Trigger finger 1/125 (0.8%) 1 0/136 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colonic polyp 0/125 (0%) 0 1/136 (0.7%) 1
    Nervous system disorders
    Carpal tunnel syndrome 0/125 (0%) 0 1/136 (0.7%) 1
    Dizziness 1/125 (0.8%) 1 1/136 (0.7%) 1
    Headache 0/125 (0%) 0 9/136 (6.6%) 9
    Migraine 1/125 (0.8%) 1 0/136 (0%) 0
    Migraine 1/125 (0.8%) 1 0/136 (0%) 0
    Muscular weakness 0/125 (0%) 0 1/136 (0.7%) 1
    Parkison's disease 0/125 (0%) 0 1/136 (0.7%) 1
    Syncope 1/125 (0.8%) 1 0/136 (0%) 0
    Vertigo 0/125 (0%) 0 1/136 (0.7%) 1
    Renal and urinary disorders
    Nephrolithiasis 0/125 (0%) 0 1/136 (0.7%) 1
    Renal failure 1/125 (0.8%) 1 0/136 (0%) 0
    Renal failure acute 0/125 (0%) 0 1/136 (0.7%) 1
    Renal failure chronic 1/125 (0.8%) 1 0/136 (0%) 0
    Renal imparment 1/125 (0.8%) 1 0/136 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Cough 4/125 (3.2%) 4 4/136 (2.9%) 4
    Dyspnoea 1/125 (0.8%) 1 0/136 (0%) 0
    Epistaxis 0/125 (0%) 0 1/136 (0.7%) 1
    Lung neoplasm 0/125 (0%) 0 1/136 (0.7%) 1
    Nasal congestion 0/125 (0%) 0 1/136 (0.7%) 1
    Nasopharyngitis 5/125 (4%) 5 4/136 (2.9%) 4
    Oropharyngeal pain 0/125 (0%) 0 3/136 (2.2%) 3
    Pulmonary oedema 1/125 (0.8%) 1 0/136 (0%) 0
    Sinusitis 2/125 (1.6%) 2 0/136 (0%) 0
    Sleep apnoea syndrome 0/125 (0%) 0 1/136 (0.7%) 1
    Skin and subcutaneous tissue disorders
    Cellulitis 1/125 (0.8%) 1 0/136 (0%) 0
    Dermal cyst 0/125 (0%) 0 1/136 (0.7%) 1
    Eczema 1/125 (0.8%) 1 0/136 (0%) 0
    Skin ulcer 0/125 (0%) 0 2/136 (1.5%) 2
    Surgical and medical procedures
    Coronary arterial stent insertion 0/125 (0%) 0 1/136 (0.7%) 1
    Vascular disorders
    Arteriovenous fistula 2/125 (1.6%) 2 1/136 (0.7%) 1
    Diabetic foot 1/125 (0.8%) 1 0/136 (0%) 0
    Hypertension 3/125 (2.4%) 3 4/136 (2.9%) 4

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Adam R. Glassman
    Organization Diabetic Retinopathy Clinical Research Network
    Phone 813-975-8761
    Email drcrstat4@jaeb.org
    Responsible Party:
    Jaeb Center for Health Research
    ClinicalTrials.gov Identifier:
    NCT00996437
    Other Study ID Numbers:
    • NEI-151
    • U10EY018817-03
    • U10EY014231-09
    First Posted:
    Oct 16, 2009
    Last Update Posted:
    Aug 26, 2016
    Last Verified:
    Aug 1, 2016