Ozurdex as Adjunct to Avastin Compared to Avastin Alone in Treatment of Patients With Diabetic Macular Edema

• Sponsor: Maturi, Raj K., M.D., P.C. (Other)
• Overall Status: Completed
• CT.gov ID: NCT01309451
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 25
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

The investigators hypothesize that a combination treatment with Avastin and Ozurdex will result in a more rapid improvement of visual acuity compared to the use of Avastin alone.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Macular Edema	Drug: Bevacizumab; Drug: dexamethasone intravitreal implant	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Single Masked, Randomized Controlled Study to Assess Efficacy of Ozurdex as Adjunct to Avastin Compared With Avastin Alone in the Treatment of Patients With Diabetic Macular Edema
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: Apr 1, 2013
• Actual Study Completion Date: Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Bevacizumab alone	Drug: Bevacizumab; intravitreal, 1.25mg., monthly; Other Names: Avastin
Active Comparator: Combined group Bevacizumab plus Ozurdex	Drug: Bevacizumab; intravitreal, 1.25mg., monthly; Other Names: Avastin ; Drug: dexamethasone intravitreal implant; 0.7mg, intravitreal every 4 months; Other Names: Ozurdex

Outcome Measures

Primary Outcome Measures

1. Change in Best Corrected Visual Acuity (BCVA) Measured Using Early Treatment of Diabetic Retinopathy Study (ETDRS) Methodology at Month 12 Compared to Baseline [baseline to 12 month]

   Visual Acuity was measured with the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity test. Unit of measure is based on the ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.

2. OCT CST [change in OCT CST from baseline to twelve months]

   change in optical coherence tomography central subfield thickness

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Male or female age 18 years or older

• Type 1 or type 2 diabetes

• BCVA score of >24 and <78 letters

• Presence of DME defined as Optical Coherence Tomography Center Subfield Thickness (OCT CST) >250microns

Exclusion Criteria:

• Anti-VEGF intravitreal treatment in last 4 weeks

• Intravitreal steroid treatment in the last 8 weeks

• PRP or Focal laser in last 4 months

• Active iris neovascularization

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Raj K. Maturi, MD	Indianapolis	Indiana	United States	46290

Sponsors and Collaborators

• Maturi, Raj K., M.D., P.C.

Investigators

• Principal Investigator: Raj K Maturi, MD, Midwest Eye Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Raj K. Maturi, MD, PI, Maturi, Raj K., M.D., P.C.
• ClinicalTrials.gov Identifier: NCT01309451
• Other Study ID Numbers: OA002
• First Posted: Mar 7, 2011
• Last Update Posted: Oct 29, 2014
• Last Verified: Oct 1, 2014

• Keywords provided by Raj K. Maturi, MD, PI, Maturi, Raj K., M.D., P.C.: diabetic macular edema; DME
• Additional relevant MeSH terms: Macular Edema; Edema; Dexamethasone; Bevacizumab

Study Results

Participant Flow

Recruitment Details	The study was conducted at a single center. The sample size was 40 eyes (30 subjects, 10 subjects had both eyes in study)
Pre-assignment Detail	Subjects were randomly assigned to either bevacizumab alone or bevacizumab plus Ozurdex in a 1:1 ratio. When both eyes were eligible, the right eye was randomized and the left eye was assigned to the other group. We had a total of 30 subjects, 10 with both eyes. 19 eyes were in the Bevacizumab Alone group and 21 eyes were in the Combined Group.

Arm/Group Title	Bevacizumab Alone	Combined Group
Arm/Group Description	monthly injection of bevacizumab intravitreally when retreatment criteria met	bevacizumab plus Ozurdex group received bevacizumab at baseline followed by Ozurdex at the one month visit. Retreatment with bevaciumab given at monthly intervals when retreatment criteria met except for months 5 and 10 when retreatment with Ozurdex was given.
Period Title: Overall Study
STARTED	19	21
COMPLETED	17	18
NOT COMPLETED	2	3

Baseline Characteristics

Arm/Group Title	Bevacizumab Alone	Combine Group	Total
Arm/Group Description	Bevacizumab only	Bevacizumab plus Ozurdex	Total of all reporting groups
Overall Participants	19	21	40
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	5 26.3%	5 23.8%	10 25%
>=65 years	14 73.7%	16 76.2%	30 75%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62 (9)	59 (12)	60.5 (10)
Sex: Female, Male (Count of Participants)
Female	9 47.4%	10 47.6%	19 47.5%
Male	10 52.6%	11 52.4%	21 52.5%
Region of Enrollment (eyes) [Number]
United States	19	21	40

Outcome Measures

1. Primary Outcome

Title	Change in Best Corrected Visual Acuity (BCVA) Measured Using Early Treatment of Diabetic Retinopathy Study (ETDRS) Methodology at Month 12 Compared to Baseline
Description	Visual Acuity was measured with the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity test. Unit of measure is based on the ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
Time Frame	baseline to 12 month

Outcome Measure Data

Analysis Population Description

The unit of measure is EYES rather than actual number of participants

Arm/Group Title	Bevacizumab Alone	Combined Group
Arm/Group Description	Bevacizumab: intravitreal, 1.25mg., monthly	Bevacizumab plus Ozurdex Bevacizumab: intravitreal, 1.25mg., monthly dexamethasone intravitreal implant: 0.7mg, intravitreal every 4 months
Measure Participants	19	21
Mean (Standard Deviation) [letters]	4.9 (12.3)	5.4 (10.7)

2. Primary Outcome

Title	OCT CST
Description	change in optical coherence tomography central subfield thickness
Time Frame	change in OCT CST from baseline to twelve months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bevacizumab Alone	Combined Group
Arm/Group Description	monthly injection of bevacizumab intravitreally when retreatment criteria met	bevacizumab plus Ozurdex group received bevacizumab at baseline followed by Ozurdex at the one month visit. Retreatment with bevaciumab given at monthly intervals when retreatment criteria met except for months 5 and 10 when retreatment with Ozurdex was given.
Measure Participants	19	21
Mean (Standard Deviation) [microns]	30 (100)	45 (107)

Adverse Events

Time Frame	1 year
Arm/Group Title	Bevacizumab Alone Group		Combined Group
Arm/Group Description	bevacizumab 1.25mg intravitreally		bevacizumab 1.25mg intravitreally plus Ozurdex THIS GROUP ALSO INCLUDES PARTICIPANTS WHO HAD BOTH EYES IN THE STUDY (they received bevacizumab alone in one eye and bavacizumab + Ozurdex in the other.
All Cause Mortality
	Bevacizumab Alone Group		Combined Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Bevacizumab Alone Group		Combined Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/9 (22.2%)		8/21 (38.1%)
Blood and lymphatic system disorders
pancytopenia	0/9 (0%)	0	1/21 (4.8%)	1
Cardiac disorders
coronary artery disease	0/9 (0%)	0	1/21 (4.8%)	1
worsening of hypertension	0/9 (0%)	0	1/21 (4.8%)	1
General disorders
generalized weakness	0/9 (0%)	0	1/21 (4.8%)	1
Infections and infestations
cellulitis	0/9 (0%)	0	1/21 (4.8%)	1
Metabolism and nutrition disorders
hyperkalemia	0/9 (0%)	0	1/21 (4.8%)	1
Musculoskeletal and connective tissue disorders
spinal stenosis	1/9 (11.1%)	1	0/21 (0%)	0
Renal and urinary disorders
acute renal insufficiency	1/9 (11.1%)	1	1/21 (4.8%)	1
Respiratory, thoracic and mediastinal disorders
pneumonia	0/9 (0%)		1/21 (4.8%)	1
Vascular disorders
cerebrovascular accident	1/9 (11.1%)	1	0/21 (0%)	0
Other (Not Including Serious) Adverse Events
	Bevacizumab Alone Group		Combined Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/9 (100%)		21/21 (100%)
Blood and lymphatic system disorders
anemia	0/9 (0%)	0	2/21 (9.5%)	2
Cardiac disorders
angina	0/9 (0%)	0	1/21 (4.8%)	1
congestive heart failure	0/9 (0%)	0	1/21 (4.8%)	1
coronary artery disease	0/9 (0%)	0	2/21 (9.5%)	2
peripheral vascular insufficiency	1/9 (11.1%)	1	0/21 (0%)	0
worsening of coronary artery disease	1/9 (11.1%)	1	1/21 (4.8%)	1
worsening of hypertension	0/9 (0%)	0	4/21 (19%)	4
worsening of peripheral vascular disease	0/9 (0%)	0	1/21 (4.8%)	1
Ear and labyrinth disorders
otitis media	0/9 (0%)	0	1/21 (4.8%)	1
vertigo	0/9 (0%)	0	1/21 (4.8%)	1
Endocrine disorders
hypothyroidism	0/9 (0%)	0	1/21 (4.8%)	1
worsening of diabetes mellitus	0/9 (0%)	0	1/21 (4.8%)	1
Eye disorders
corneal abrasion	1/9 (11.1%)	1	0/21 (0%)	0
corneal precipatates	0/9 (0%)	0	1/21 (4.8%)	1
cyst lower eyelid	1/9 (11.1%)	1	0/21 (0%)	0
decreased visual acuity	0/9 (0%)	0	1/21 (4.8%)	1
ocular discomfort	1/9 (11.1%)	1	0/21 (0%)	0
dry eye syndrome	0/9 (0%)	0	1/21 (4.8%)	1
epiretinal membrane	5/9 (55.6%)	5	4/21 (19%)	4
vitreous floater	1/9 (11.1%)	1	4/21 (19%)	4
suspected glaucoma	1/9 (11.1%)	1	1/21 (4.8%)	1
hordeolum lower eyelid	1/9 (11.1%)	1	0/21 (0%)	0
increased intraocular pressure	2/9 (22.2%)	2	6/21 (28.6%)	8
iritis	0/9 (0%)	0	1/21 (4.8%)	1
keratitis	0/9 (0%)	0	2/21 (9.5%)	2
low tension glaucoma	0/9 (0%)	0	1/21 (4.8%)	1
macular scar	0/9 (0%)	0	1/21 (4.8%)	1
neovascularization of retina	3/9 (33.3%)	3	1/21 (4.8%)	2
posterior capsule opacification	0/9 (0%)	0	6/21 (28.6%)	6
subconjunctival hemorrhage	0/9 (0%)	0	1/21 (4.8%)	1
tear film insufficiency	0/9 (0%)	0	1/21 (4.8%)	1
visual disturbance	1/9 (11.1%)	1	0/21 (0%)	0
vitreous hemorrhage	0/9 (0%)	0	1/21 (4.8%)	1
worsening of cataract	7/9 (77.8%)	7	8/21 (38.1%)	8
worsening of posterior capsule opacification	0/9 (0%)	0	1/21 (4.8%)	1
worsening of vitreoretinal traction	0/9 (0%)	0	1/21 (4.8%)	1
worsening of vitreous hemorrhage	0/9 (0%)	0	1/21 (4.8%)	1
Gastrointestinal disorders
heartburn	1/9 (11.1%)	1	0/21 (0%)	0
General disorders
cough	0/9 (0%)	0	2/21 (9.5%)	2
dizziness	2/9 (22.2%)	2	0/21 (0%)	0
Infections and infestations
canaliculitis	1/9 (11.1%)	1	0/21 (0%)	0
cellulitis	0/9 (0%)	0	2/21 (9.5%)	2
esophageal candidiasis	1/9 (11.1%)	1	0/21 (0%)	0
esophageal candidiasis	0/9 (0%)	0	1/21 (4.8%)	1
infection of toe	0/9 (0%)	0	1/21 (4.8%)	1
nail fungus	0/9 (0%)	0	2/21 (9.5%)	2
poison ivy	1/9 (11.1%)	1	0/21 (0%)	0
sinusitis	0/9 (0%)	0	5/21 (23.8%)	5
foot ulcer	0/9 (0%)	0	1/21 (4.8%)	1
Injury, poisoning and procedural complications
laceration right leg	0/9 (0%)	0	1/21 (4.8%)	1
ankle sprain	0/9 (0%)	0	1/21 (4.8%)	1
Metabolism and nutrition disorders
hypokalemia	0/9 (0%)	0	1/21 (4.8%)	1
loss of blood sugar control	1/9 (11.1%)	1	5/21 (23.8%)	5
magnesium deficiency	0/9 (0%)	0	1/21 (4.8%)	1
vitamin D deficiency	0/9 (0%)	0	1/21 (4.8%)	1
Musculoskeletal and connective tissue disorders
osteophyte right foot	1/9 (11.1%)	1	0/21 (0%)	0
carpal tunnel syndrome	0/9 (0%)	0	1/21 (4.8%)	1
degenerative joint disease	1/9 (11.1%)	1	0/21 (0%)	0
fallen arch left foot	0/9 (0%)	0	1/21 (4.8%)	1
fracture ribs	0/9 (0%)	0	1/21 (4.8%)	1
adhesive capsulitis	0/9 (0%)	0	1/21 (4.8%)	1
knee pain	0/9 (0%)	0	2/21 (9.5%)	2
low back bain	0/9 (0%)	0	2/21 (9.5%)	2
heel discomfort	0/9 (0%)	0	1/21 (4.8%)	1
sleep apnea	1/9 (11.1%)	1	2/21 (9.5%)	2
tendonitis	0/9 (0%)	0	1/21 (4.8%)	1
Nervous system disorders
headaches	1/9 (11.1%)	1	1/21 (4.8%)	1
sciatica	0/9 (0%)	0	1/21 (4.8%)	1
Psychiatric disorders
anxiety	0/9 (0%)	0	1/21 (4.8%)	1
decreased ability to concentrate	0/9 (0%)	0	1/21 (4.8%)	1
Renal and urinary disorders
renal insufficiency	1/9 (11.1%)	1	1/21 (4.8%)	1
peripheral edema	0/9 (0%)	0	1/21 (4.8%)	1
hematuria	1/9 (11.1%)	1	0/21 (0%)	0
Respiratory, thoracic and mediastinal disorders
bronchitis	0/9 (0%)	0	2/21 (9.5%)	2
nasal congestion	1/9 (11.1%)	1	1/21 (4.8%)	1
pneumonia	0/9 (0%)	0	3/21 (14.3%)	4
upper respiratory infection	2/9 (22.2%)	2	2/21 (9.5%)	2
Skin and subcutaneous tissue disorders
blepharitis	0/9 (0%)	0	1/21 (4.8%)	1
contusion left arm	1/9 (11.1%)	1	0/21 (0%)	0

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.