Use of Intravitreal Aflibercept Injection for Neovascular Glaucoma

• Sponsor: University of Colorado, Denver (Other)
• Overall Status: Completed
• CT.gov ID: NCT01711879
• Collaborator: (none)
• Enrollment: 7
• Location: 1
• Arms: 2
• Duration (Months): 33
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This 52 week study will assess the use of intravitreal aflibercept injections in patients with neovascular glaucoma (NVG) compared to standard of care panretinal photocoagulation.

The investigators hypothesize that the neovascularization of the iris and angle present in neovascular glaucoma will resolve more quickly in eye treated with intravitreal aflibercept injection alone and result in increased comfort and preservation of visual field as compared to current standard of care utilizing pan-retinal photocoagulation. The advantages to intravitreal aflibercept injection use could include resolution of NVI/NVA (neovascularization of the iris/neovascularization of the angle) leading to quicker pain relief and quicker lowering of IOP (intraocular pressure).

Condition or Disease	Intervention/Treatment	Phase
Neovascular Glaucoma	Drug: Aflibercept	N/A

Detailed Description

The two arms of this study will compare current common practice (initial intravitreal anti-VEGF (vascular endothelial growth factor) to study treatment (VEGF) injection only) for 52 weeks.

This single center study will consist of 20 patients with NVG. Patients will be randomized to:

• Group A: A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks.

or

• Group B: 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.

Clinical assessment will include pain assessment (Universal Pain Scale), best corrected visual acuity (ETDRS), ophthalmic examination, anterior segment assessment including number of clock-hours of NVI/NVA, gonioscopy, anterior segment photography, visual field test (Humphrey SITA- Standard 24-2), optic nerve OCT (Zeiss Cirrus Optic Disc Cube 200x200), macular OCT (Cube scan 512 x 128 and 5 Line Raster), fluorescein angiography (initial iris phase followed by standard retinal angiography), and concurrent medical/ocular medications. Qualitative assessment of neovascularization will be made by the investigator based on comparison to baseline angiography.

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Use of Intravitreal Aflibercept Injection for Neovascular Glaucoma
• Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Aflibercept with Laser A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks	Drug: Aflibercept; Details covered in arm description; Other Names: Eylea
Experimental: Aflibercept 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.	Drug: Aflibercept; Details covered in arm description; Other Names: Eylea

Outcome Measures

Primary Outcome Measures

1. Incidence of Adverse Events [2 year]

   Assess the safety profile of repeated intravitreal aflibercept injections in patients with NVG by evaluating the incidence of adverse events

2. Severity of Adverse Events [2 year]

   Assess the safety profile of repeated intravitreal aflibercept injections in patients with NVG by evaluating the severity of adverse events

Secondary Outcome Measures

1. Rate and Extent of Resolution of Neovascularization [1 year]

   Compare between Groups A and B the Rate and extent of resolution of neovascularization in patients with NVG Stages 1 & 2.

2. Intraocular Pressure (mmHg) at Baseline [Baseline]

   Intraocular pressure(mmHg) as measured by Goldmann applanation tonometry between groups A and B

3. Intraocular Pressure (mmHg) at Week 52 [Week 52]

   Mean intraocular pressure(mmHg) as measured by Goldmann applanation tonometry between groups A and B

4. Number of Patients Losing > 5 Letters on Visual Acuity in Each Group A and Group B [Baseline to Week 52]

   Comparison between patients, groups A and B, that lost > 5 letters on visual acuity

5. Number of Patients in Each, Group A and Group B, Gaining > 5 Letters on Visual Acuity [Baseline to Week 52]

   Comparison of patients in each, group A and group B, that gained > 5 letters on visual acuity

6. Visual Acuity at Baseline [Baseline]

   Comparison of visual acuity between groups A and B

7. Visual Acuity at Week 52 [Week 52]

   Comparison of visual acuity at Week 52 between groups A and B

8. Comparison of the Visual Field Between Groups [1 year]

   Comparison of the Visual field s measured by HVF 24-2 SITA Standards between groups A and B

9. Measure of the Optical Coherence Tomography(OCT) Outcomes [Baseline to Week 52]

   Evaluation of the Optical Coherence Tomography(OCT) outcomes (average retinal nerve fiber layer(RNFL) and central macular thickness), Compared between groups A and B.

10. Number of Patients With Need for Surgical Intervention [1 year]

    Comparison between groups A and B and the need for surgical intervention in both arms during the follow-up period

11. Number of Participants With Need for Additional IOP Lowering Medications [1 year]

    Comparison between groups A and B for the need of additional IOP lowering medications

12. Extent of Resolution of Neovascularization Between Groups [1 year]

    Comparison of groups A and B and the extent of resolution of neovascularization in patients with NVG Stages 1 & 2

13. Evaluation of the Average Retinal Nerve Fiber Layer (RNFL) [1 year]

    Comparison between groups A and B of the average retinal nerve fiber layer (RNFL) as measured by Optical Coherence Tomography (OCT)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with a diagnosis of neovascular glaucoma (Stage I-II)

• Individuals who are ages 21-90 years old; male or female of any race

• Presence of neovascularization of the iris and/or angle

• At least 90 degrees of "unzipped" anterior chamber angle as noted by gonioscopy. (a "zipped angle is the term used for a drainage angle that is slowly closing due to scar tissue from the neovascularization process)

• Visual acuity of light perception or better in the study eye

• Willing and able to comply with clinic visits and study-related procedures

• Provide signed informed consent

Exclusion Criteria:

• Use of intravitreal anti-VEGF agents in the study eye in the past 3 months.

• Full PRP in the study eye

• Prior vitrectomy in the study eye

• Prior trabeculectomy or other filtration surgery in the study eye

• Active ocular or periocular infection in the study eye

• Ocular conditions (Cataract or vitreous hemorrhage) that might require surgery in next 12 months

• Allergy to fluorescein dye

• Any past use of systemic anti-VEGF medication

• Myocardial infarction within 6 months prior to study enrollment

• Stroke within 6 months prior to study enrollment

• Pregnant or breast-feeding women

• Sexually active men or women of childbearing potential who are unwilling to practice adequate contraception during the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rocky Mountain Lions Eye Institute	Aurora	Colorado	United States	80045

Sponsors and Collaborators

• University of Colorado, Denver

Investigators

• Principal Investigator: Malik Y Kahook, MD, University of Colorado, Denver

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT01711879
• Other Study ID Numbers: 12-1526
• First Posted: Oct 22, 2012
• Last Update Posted: Mar 18, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Neovascular; Aflibercept

Study Results

Participant Flow

Arm/Group Title	Aflibercept With Laser	Aflibercept
Arm/Group Description	A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks	2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
Period Title: Overall Study
STARTED	3	4
COMPLETED	2	4
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Aflibercept With Laser	Aflibercept	Total
Arm/Group Description	A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks Aflibercept: Details covered in arm description	2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks. Aflibercept: Details covered in arm description	Total of all reporting groups
Overall Participants	3	4	7
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	3 100%	2 50%	5 71.4%
>=65 years	0 0%	2 50%	2 28.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.33 (5.69)	61.5 (15.63)	59.29 (11.86)
Sex: Female, Male (Count of Participants)
Female	3 100%	3 75%	6 85.7%
Male	0 0%	1 25%	1 14.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 100%	3 75%	6 85.7%
Not Hispanic or Latino	0 0%	1 25%	1 14.3%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Incidence of Adverse Events
Description	Assess the safety profile of repeated intravitreal aflibercept injections in patients with NVG by evaluating the incidence of adverse events
Time Frame	2 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aflibercept With Laser	Aflibercept
Arm/Group Description	A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks	2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
Measure Participants	3	4
Count of Participants [Participants]	3 100%	4 100%

2. Primary Outcome

Title	Severity of Adverse Events
Description	Assess the safety profile of repeated intravitreal aflibercept injections in patients with NVG by evaluating the severity of adverse events
Time Frame	2 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aflibercept With Laser	Aflibercept
Arm/Group Description	A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks	2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
Measure Participants	3	4
Mild	0 0%	1 25%
Moderate	0 0%	0 0%
Severe	0 0%	0 0%
None	3 100%	3 75%
Mild	0 0%	1 25%
Moderate	0 0%	0 0%
Severe	0 0%	0 0%
None	3 100%	3 75%
Mild	0 0%	1 25%
Moderate	0 0%	0 0%
Severe	0 0%	0 0%
None	3 100%	3 75%
Mild	2 66.7%	0 0%
Moderate	0 0%	0 0%
Severe	0 0%	0 0%
None	1 33.3%	4 100%
Mild	0 0%	1 25%
Moderate	0 0%	0 0%
Severe	0 0%	0 0%
None	3 100%	3 75%
Mild	1 33.3%	1 25%
Moderate	1 33.3%	0 0%
Severe	0 0%	0 0%
None	1 33.3%	3 75%
Mild	0 0%	1 25%
Moderate	0 0%	0 0%
Severe	0 0%	0 0%
None	3 100%	3 75%
Mild	0 0%	1 25%
Moderate	0 0%	0 0%
Severe	0 0%	0 0%
None	3 100%	3 75%
Mild	0 0%	1 25%
Moderate	0 0%	0 0%
Severe	0 0%	0 0%
None	3 100%	3 75%
Mild	0 0%	0 0%
Moderate	0 0%	0 0%
Severe	1 33.3%	0 0%
None	2 66.7%	4 100%
Mild	0 0%	1 25%
Moderate	0 0%	0 0%
Severe	0 0%	0 0%
None	3 100%	3 75%
Mild	0 0%	0 0%
Moderate	0 0%	0 0%
Severe	1 33.3%	0 0%
None	2 66.7%	4 100%
Mild	0 0%	1 25%
Moderate	0 0%	0 0%
Severe	0 0%	0 0%
None	3 100%	3 75%

3. Secondary Outcome

Title	Rate and Extent of Resolution of Neovascularization
Description	Compare between Groups A and B the Rate and extent of resolution of neovascularization in patients with NVG Stages 1 & 2.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

No data was collected or analyzed for this Outcome Measure

Arm/Group Title	Aflibercept With Laser	Aflibercept
Arm/Group Description	A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks	2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
Measure Participants	0	0

4. Secondary Outcome

Title	Intraocular Pressure (mmHg) at Baseline
Description	Intraocular pressure(mmHg) as measured by Goldmann applanation tonometry between groups A and B
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

One participant from group Aflibercept with Laser did not complete analysis due to death. Analysis is limited due to small sample size.

Arm/Group Title	Aflibercept With Laser	Aflibercept
Arm/Group Description	A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks	2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
Measure Participants	2	4
Study Eye Mean IOP(mmHg) at Baseline	10	23.5
Fellow Eye Mean IOP(mmHg) at Baseline	11	22.75

5. Secondary Outcome

Title	Intraocular Pressure (mmHg) at Week 52
Description	Mean intraocular pressure(mmHg) as measured by Goldmann applanation tonometry between groups A and B
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

One participant from group Aflibercept with Laser did not complete analysis due to death. Analysis is limited due to small sample size.

Arm/Group Title	Aflibercept With Laser	Aflibercept
Arm/Group Description	A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks	2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
Measure Participants	2	4
Study Eye Mean IOP(mmHg) at W52	10	15.25
Fellow Eye Mean IOP(mmHg) at W52	10	14

6. Secondary Outcome

Title	Number of Patients Losing > 5 Letters on Visual Acuity in Each Group A and Group B
Description	Comparison between patients, groups A and B, that lost > 5 letters on visual acuity
Time Frame	Baseline to Week 52

Outcome Measure Data

Analysis Population Description

One participant from group Aflibercept with Laser did not complete analysis due to death. Analysis is limited due to small sample size.

Arm/Group Title	Aflibercept With Laser	Aflibercept
Arm/Group Description	A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks	2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
Measure Participants	3	3
Number [participants]	0 0%	0 0%

7. Secondary Outcome

Title	Number of Patients in Each, Group A and Group B, Gaining > 5 Letters on Visual Acuity
Description	Comparison of patients in each, group A and group B, that gained > 5 letters on visual acuity
Time Frame	Baseline to Week 52

Outcome Measure Data

Analysis Population Description

One participant from group Aflibercept with Laser did not complete analysis due to death. Analysis is limited due to small sample size.

Arm/Group Title	Aflibercept With Laser	Aflibercept
Arm/Group Description	A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks	2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
Measure Participants	3	3
Number [participants]	2 66.7%	0 0%

8. Secondary Outcome

Title	Visual Acuity at Baseline
Description	Comparison of visual acuity between groups A and B
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

One participant from group Aflibercept with Laser did not complete analysis due to death. Analysis is limited due to small sample size.

Arm/Group Title	Aflibercept With Laser	Aflibercept
Arm/Group Description	A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks	2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
Measure Participants	2	4
Mean (Full Range) [Letters]	64	37.5

9. Secondary Outcome

Title	Visual Acuity at Week 52
Description	Comparison of visual acuity at Week 52 between groups A and B
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

One participant from group Aflibercept with Laser did not complete analysis due to death. Analysis is limited due to small sample size.

Arm/Group Title	Aflibercept With Laser	Aflibercept
Arm/Group Description	A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks	2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
Measure Participants	2	4
Study Eye Mean W52 Number of ETDRS Letters	33.5	62
Fellow Eye Mean W52 Number of ETDRS Letters	32	46.75

10. Secondary Outcome

Title	Comparison of the Visual Field Between Groups
Description	Comparison of the Visual field s measured by HVF 24-2 SITA Standards between groups A and B
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

No data was collected or analyzed for this Outcome Measure during the clinical trial.

Arm/Group Title	Aflibercept With Laser	Aflibercept
Arm/Group Description	A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks	2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
Measure Participants	0	0

11. Secondary Outcome

Title	Measure of the Optical Coherence Tomography(OCT) Outcomes
Description	Evaluation of the Optical Coherence Tomography(OCT) outcomes (average retinal nerve fiber layer(RNFL) and central macular thickness), Compared between groups A and B.
Time Frame	Baseline to Week 52

Outcome Measure Data

Analysis Population Description

The database in OCT was corrupted and the data was lost

Arm/Group Title	Aflibercept With Laser	Aflibercept
Arm/Group Description	A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks Aflibercept: Details covered in arm description	2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks. Aflibercept: Details covered in arm description
Measure Participants	0	0

12. Secondary Outcome

Title	Number of Patients With Need for Surgical Intervention
Description	Comparison between groups A and B and the need for surgical intervention in both arms during the follow-up period
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

One participant from group Aflibercept with Laser did not complete analysis due to death. Analysis is limited due to small sample size.

Arm/Group Title	Aflibercept With Laser	Aflibercept
Arm/Group Description	A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks	2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
Measure Participants	3	3
Number [participants]	0 0%	0 0%

13. Secondary Outcome

Title	Number of Participants With Need for Additional IOP Lowering Medications
Description	Comparison between groups A and B for the need of additional IOP lowering medications
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aflibercept With Laser	Aflibercept
Arm/Group Description	A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks	2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
Measure Participants	2	4
Number [participants]	0 0%	0 0%

14. Secondary Outcome

Title	Extent of Resolution of Neovascularization Between Groups
Description	Comparison of groups A and B and the extent of resolution of neovascularization in patients with NVG Stages 1 & 2
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

NVG Staging not recorded

Arm/Group Title	Aflibercept With Laser	Aflibercept
Arm/Group Description	A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks	2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
Measure Participants	0	0

15. Secondary Outcome

Title	Evaluation of the Average Retinal Nerve Fiber Layer (RNFL)
Description	Comparison between groups A and B of the average retinal nerve fiber layer (RNFL) as measured by Optical Coherence Tomography (OCT)
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The OCT database was corrupted and the data was lost

Arm/Group Title	Aflibercept With Laser	Aflibercept
Arm/Group Description	A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks	2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
Measure Participants	0	0

Adverse Events

Time Frame	2 years
Arm/Group Title	Aflibercept With Laser		Aflibercept
Arm/Group Description	A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks		2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
All Cause Mortality
	Aflibercept With Laser		Aflibercept
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/3 (33.3%)		0/4 (0%)
Serious Adverse Events
	Aflibercept With Laser		Aflibercept
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/3 (33.3%)		0/4 (0%)
General disorders
Death	1/3 (33.3%)	1	0/4 (0%)	0
Other (Not Including Serious) Adverse Events
	Aflibercept With Laser		Aflibercept
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/3 (100%)		4/4 (100%)
Endocrine disorders
Diabetes Mellitus	0/3 (0%)	0	1/4 (25%)	1
Eye disorders
Vitreous hemmorrhage	2/3 (66.7%)	2	0/4 (0%)	0
Worsening cataract non-study eye	0/3 (0%)	0	1/4 (25%)	1
Worsening Cataract Study eye	2/3 (66.7%)	2	1/4 (25%)	1
Worsening NVG - non-study eye	0/3 (0%)	0	1/4 (25%)	1
Gastrointestinal disorders
progression of gall bladder cancer	1/3 (33.3%)	1	0/4 (0%)	0
metastatic cancer affecting liver	1/3 (33.3%)	1	0/4 (0%)	0
Musculoskeletal and connective tissue disorders
worsening arthritis right knee	0/3 (0%)	0	1/4 (25%)	1
Respiratory, thoracic and mediastinal disorders
Asthma	0/3 (0%)	0	1/4 (25%)	1
Pneumonia	0/3 (0%)	0	1/4 (25%)	1
shortness of breath	0/3 (0%)	0	1/4 (25%)	1
Skin and subcutaneous tissue disorders
Recurrent BCC	0/3 (0%)	0	1/4 (25%)	1
Abcess left thigh	0/3 (0%)	0	1/4 (25%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.