Neovascular Glaucoma
Conditions
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).
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.
Interventions
DRUGAflibercept
Details covered in arm description
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure (mmHg) at Week 52 | Week 52 | Mean intraocular pressure(mmHg) as measured by Goldmann applanation tonometry between groups A and B |
| 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 |
| 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 |
| Visual Acuity at Baseline | Baseline | Comparison of visual acuity between groups A and B |
| Visual Acuity at Week 52 | Week 52 | Comparison of visual acuity at Week 52 between groups A and B |
| 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. |
| 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. |
| 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 |
| 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 |
| 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 |
| 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) |
| 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 |
| Intraocular Pressure (mmHg) at Baseline | Baseline | Intraocular pressure(mmHg) as measured by Goldmann applanation tonometry between groups A and B |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
Aflibercept: Details covered in arm description | 3 |
| 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.
Aflibercept: Details covered in arm description | 4 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
Baseline characteristics
| Characteristic | Aflibercept With Laser | Aflibercept | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 2 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 2 Participants | 5 Participants |
| Age, Continuous | 56.33 years STANDARD_DEVIATION 5.69 | 61.5 years STANDARD_DEVIATION 15.63 | 59.29 years STANDARD_DEVIATION 11.86 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 3 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 3 | 0 / 4 |
| other Total, other adverse events | 3 / 3 | 4 / 4 |
| serious Total, serious adverse events | 1 / 3 | 0 / 4 |
Outcome results
Primary
Incidence of Adverse Events
Assess the safety profile of repeated intravitreal aflibercept injections in patients with NVG by evaluating the incidence of adverse events
Time frame: 2 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aflibercept With Laser | Incidence of Adverse Events | 3 Participants |
| Aflibercept | Incidence of Adverse Events | 4 Participants |
Primary
Severity of Adverse Events
Assess the safety profile of repeated intravitreal aflibercept injections in patients with NVG by evaluating the severity of adverse events
Time frame: 2 year
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Aflibercept With Laser | Severity of Adverse Events | Vitreous hemorrhage | Mild | 2 Participants |
| Aflibercept With Laser | Severity of Adverse Events | Recurrent BCC | Mild | 0 Participants |
| Aflibercept With Laser | Severity of Adverse Events | Worsening cataract non-study eye | None | 3 Participants |
| Aflibercept With Laser | Severity of Adverse Events | Recurrent BCC | Moderate | 0 Participants |
| Aflibercept With Laser | Severity of Adverse Events | Asthma | None | 3 Participants |
| Aflibercept With Laser | Severity of Adverse Events | Recurrent BCC | Severe | 0 Participants |
| Aflibercept With Laser | Severity of Adverse Events | progression of gall bladder cancer | Mild | 0 Participants |
| Aflibercept With Laser | Severity of Adverse Events | Worsening Cataract Study eye | Mild | 1 Participants |
| Aflibercept With Laser | Severity of Adverse Events | progression of gall bladder cancer | Moderate | 0 Participants |
| Aflibercept With Laser | Severity of Adverse Events | Vitreous hemorrhage | Moderate | 0 Participants |
| Aflibercept With Laser | Severity of Adverse Events | progression of gall bladder cancer | Severe | 1 Participants |
| Aflibercept With Laser | Severity of Adverse Events | Worsening Cataract Study eye | Moderate | 1 Participants |
| Aflibercept With Laser | Severity of Adverse Events | progression of gall bladder cancer | None | 2 Participants |
| Aflibercept With Laser | Severity of Adverse Events | Recurrent BCC | None | 3 Participants |
| Aflibercept With Laser | Severity of Adverse Events | worsening of arthritis Right knee | Mild | 0 Participants |
| Aflibercept With Laser | Severity of Adverse Events | Worsening Cataract Study eye | Severe | 0 Participants |
| Aflibercept With Laser | Severity of Adverse Events | worsening of arthritis Right knee | Moderate | 0 Participants |
| Aflibercept With Laser | Severity of Adverse Events | Vitreous hemorrhage | Severe | 0 Participants |
| Aflibercept With Laser | Severity of Adverse Events | worsening of arthritis Right knee | Severe | 0 Participants |
| Aflibercept With Laser | Severity of Adverse Events | Worsening Cataract Study eye | None | 1 Participants |
| Aflibercept With Laser | Severity of Adverse Events | worsening of arthritis Right knee | None | 3 Participants |
| Aflibercept With Laser | Severity of Adverse Events | Pneumonia | Mild | 0 Participants |
| Aflibercept With Laser | Severity of Adverse Events | matastatic cancer of liver | Mild | 0 Participants |
| Aflibercept With Laser | Severity of Adverse Events | Diabetes Mellitus | Mild | 0 Participants |
| Aflibercept With Laser | Severity of Adverse Events | matastatic cancer of liver | Moderate | 0 Participants |
| Aflibercept With Laser | Severity of Adverse Events | Vitreous hemorrhage | None | 1 Participants |
| Aflibercept With Laser | Severity of Adverse Events | matastatic cancer of liver | Severe | 1 Participants |
| Aflibercept With Laser | Severity of Adverse Events | Diabetes Mellitus | Moderate | 0 Participants |
| Aflibercept With Laser | Severity of Adverse Events | matastatic cancer of liver | None | 2 Participants |
| Aflibercept With Laser | Severity of Adverse Events | Pneumonia | None | 3 Participants |
| Aflibercept With Laser | Severity of Adverse Events | shortness of breath | Mild | 0 Participants |
| Aflibercept With Laser | Severity of Adverse Events | Diabetes Mellitus | Severe | 0 Participants |
| Aflibercept With Laser | Severity of Adverse Events | shortness of breath | Moderate | 0 Participants |
| Aflibercept With Laser | Severity of Adverse Events | Worsening cataract non-study eye | Mild | 0 Participants |
| Aflibercept With Laser | Severity of Adverse Events | shortness of breath | Severe | 0 Participants |
| Aflibercept With Laser | Severity of Adverse Events | Diabetes Mellitus | None | 3 Participants |
| Aflibercept With Laser | Severity of Adverse Events | shortness of breath | None | 3 Participants |
| Aflibercept With Laser | Severity of Adverse Events | Pneumonia | Moderate | 0 Participants |
| Aflibercept With Laser | Severity of Adverse Events | Abcess left thigh | Mild | 0 Participants |
| Aflibercept With Laser | Severity of Adverse Events | Worsening NVG - non-study eye | Mild | 0 Participants |
| Aflibercept With Laser | Severity of Adverse Events | Abcess left thigh | Moderate | 0 Participants |
| Aflibercept With Laser | Severity of Adverse Events | Worsening cataract non-study eye | Moderate | 0 Participants |
| Aflibercept With Laser | Severity of Adverse Events | Abcess left thigh | Severe | 0 Participants |
| Aflibercept With Laser | Severity of Adverse Events | Worsening NVG - non-study eye | Moderate | 0 Participants |
| Aflibercept With Laser | Severity of Adverse Events | Abcess left thigh | None | 3 Participants |
| Aflibercept With Laser | Severity of Adverse Events | Pneumonia | Severe | 0 Participants |
| Aflibercept With Laser | Severity of Adverse Events | Asthma | Mild | 0 Participants |
| Aflibercept With Laser | Severity of Adverse Events | Worsening NVG - non-study eye | Severe | 0 Participants |
| Aflibercept With Laser | Severity of Adverse Events | Asthma | Moderate | 0 Participants |
| Aflibercept With Laser | Severity of Adverse Events | Worsening cataract non-study eye | Severe | 0 Participants |
| Aflibercept With Laser | Severity of Adverse Events | Asthma | Severe | 0 Participants |
| Aflibercept With Laser | Severity of Adverse Events | Worsening NVG - non-study eye | None | 3 Participants |
| Aflibercept | Severity of Adverse Events | Asthma | Severe | 0 Participants |
| Aflibercept | Severity of Adverse Events | Recurrent BCC | None | 3 Participants |
| Aflibercept | Severity of Adverse Events | Pneumonia | Severe | 0 Participants |
| Aflibercept | Severity of Adverse Events | Pneumonia | None | 3 Participants |
| Aflibercept | Severity of Adverse Events | Asthma | None | 3 Participants |
| Aflibercept | Severity of Adverse Events | Pneumonia | Mild | 1 Participants |
| Aflibercept | Severity of Adverse Events | Pneumonia | Moderate | 0 Participants |
| Aflibercept | Severity of Adverse Events | Vitreous hemorrhage | Mild | 0 Participants |
| Aflibercept | Severity of Adverse Events | Vitreous hemorrhage | Moderate | 0 Participants |
| Aflibercept | Severity of Adverse Events | Vitreous hemorrhage | Severe | 0 Participants |
| Aflibercept | Severity of Adverse Events | Vitreous hemorrhage | None | 4 Participants |
| Aflibercept | Severity of Adverse Events | Worsening cataract non-study eye | Mild | 1 Participants |
| Aflibercept | Severity of Adverse Events | Worsening cataract non-study eye | Moderate | 0 Participants |
| Aflibercept | Severity of Adverse Events | Worsening cataract non-study eye | Severe | 0 Participants |
| Aflibercept | Severity of Adverse Events | Worsening cataract non-study eye | None | 3 Participants |
| Aflibercept | Severity of Adverse Events | Worsening Cataract Study eye | Mild | 1 Participants |
| Aflibercept | Severity of Adverse Events | Worsening Cataract Study eye | Moderate | 0 Participants |
| Aflibercept | Severity of Adverse Events | Worsening Cataract Study eye | Severe | 0 Participants |
| Aflibercept | Severity of Adverse Events | Worsening Cataract Study eye | None | 3 Participants |
| Aflibercept | Severity of Adverse Events | Diabetes Mellitus | Mild | 1 Participants |
| Aflibercept | Severity of Adverse Events | Diabetes Mellitus | Moderate | 0 Participants |
| Aflibercept | Severity of Adverse Events | Diabetes Mellitus | Severe | 0 Participants |
| Aflibercept | Severity of Adverse Events | Diabetes Mellitus | None | 3 Participants |
| Aflibercept | Severity of Adverse Events | Worsening NVG - non-study eye | Mild | 1 Participants |
| Aflibercept | Severity of Adverse Events | Worsening NVG - non-study eye | Moderate | 0 Participants |
| Aflibercept | Severity of Adverse Events | Worsening NVG - non-study eye | Severe | 0 Participants |
| Aflibercept | Severity of Adverse Events | Worsening NVG - non-study eye | None | 3 Participants |
| Aflibercept | Severity of Adverse Events | Recurrent BCC | Mild | 1 Participants |
| Aflibercept | Severity of Adverse Events | Recurrent BCC | Moderate | 0 Participants |
| Aflibercept | Severity of Adverse Events | progression of gall bladder cancer | Mild | 0 Participants |
| Aflibercept | Severity of Adverse Events | progression of gall bladder cancer | Moderate | 0 Participants |
| Aflibercept | Severity of Adverse Events | progression of gall bladder cancer | Severe | 0 Participants |
| Aflibercept | Severity of Adverse Events | progression of gall bladder cancer | None | 4 Participants |
| Aflibercept | Severity of Adverse Events | worsening of arthritis Right knee | Mild | 1 Participants |
| Aflibercept | Severity of Adverse Events | worsening of arthritis Right knee | Moderate | 0 Participants |
| Aflibercept | Severity of Adverse Events | worsening of arthritis Right knee | Severe | 0 Participants |
| Aflibercept | Severity of Adverse Events | worsening of arthritis Right knee | None | 3 Participants |
| Aflibercept | Severity of Adverse Events | matastatic cancer of liver | Mild | 0 Participants |
| Aflibercept | Severity of Adverse Events | matastatic cancer of liver | Moderate | 0 Participants |
| Aflibercept | Severity of Adverse Events | matastatic cancer of liver | Severe | 0 Participants |
| Aflibercept | Severity of Adverse Events | matastatic cancer of liver | None | 4 Participants |
| Aflibercept | Severity of Adverse Events | shortness of breath | Mild | 1 Participants |
| Aflibercept | Severity of Adverse Events | shortness of breath | Moderate | 0 Participants |
| Aflibercept | Severity of Adverse Events | shortness of breath | Severe | 0 Participants |
| Aflibercept | Severity of Adverse Events | shortness of breath | None | 3 Participants |
| Aflibercept | Severity of Adverse Events | Abcess left thigh | Mild | 1 Participants |
| Aflibercept | Severity of Adverse Events | Abcess left thigh | Moderate | 0 Participants |
| Aflibercept | Severity of Adverse Events | Abcess left thigh | Severe | 0 Participants |
| Aflibercept | Severity of Adverse Events | Abcess left thigh | None | 3 Participants |
| Aflibercept | Severity of Adverse Events | Asthma | Mild | 1 Participants |
| Aflibercept | Severity of Adverse Events | Asthma | Moderate | 0 Participants |
| Aflibercept | Severity of Adverse Events | Recurrent BCC | Severe | 0 Participants |
Secondary
Comparison of the Visual Field Between Groups
Comparison of the Visual field s measured by HVF 24-2 SITA Standards between groups A and B
Time frame: 1 year
Population: No data was collected or analyzed for this Outcome Measure during the clinical trial.
Secondary
Evaluation of the Average Retinal Nerve Fiber Layer (RNFL)
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
Population: The OCT database was corrupted and the data was lost
Secondary
Extent of Resolution of Neovascularization Between Groups
Comparison of groups A and B and the extent of resolution of neovascularization in patients with NVG Stages 1 & 2
Time frame: 1 year
Population: NVG Staging not recorded
Secondary
Intraocular Pressure (mmHg) at Baseline
Intraocular pressure(mmHg) as measured by Goldmann applanation tonometry between groups A and B
Time frame: Baseline
Population: One participant from group Aflibercept with Laser did not complete analysis due to death. Analysis is limited due to small sample size.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Aflibercept With Laser | Intraocular Pressure (mmHg) at Baseline | Study Eye Mean IOP(mmHg) at Baseline | 10 mmHg |
| Aflibercept With Laser | Intraocular Pressure (mmHg) at Baseline | Fellow Eye Mean IOP(mmHg) at Baseline | 11 mmHg |
| Aflibercept | Intraocular Pressure (mmHg) at Baseline | Study Eye Mean IOP(mmHg) at Baseline | 23.5 mmHg |
| Aflibercept | Intraocular Pressure (mmHg) at Baseline | Fellow Eye Mean IOP(mmHg) at Baseline | 22.75 mmHg |
Secondary
Intraocular Pressure (mmHg) at Week 52
Mean intraocular pressure(mmHg) as measured by Goldmann applanation tonometry between groups A and B
Time frame: Week 52
Population: One participant from group Aflibercept with Laser did not complete analysis due to death. Analysis is limited due to small sample size.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Aflibercept With Laser | Intraocular Pressure (mmHg) at Week 52 | Study Eye Mean IOP(mmHg) at W52 | 10 mmHg |
| Aflibercept With Laser | Intraocular Pressure (mmHg) at Week 52 | Fellow Eye Mean IOP(mmHg) at W52 | 10 mmHg |
| Aflibercept | Intraocular Pressure (mmHg) at Week 52 | Study Eye Mean IOP(mmHg) at W52 | 15.25 mmHg |
| Aflibercept | Intraocular Pressure (mmHg) at Week 52 | Fellow Eye Mean IOP(mmHg) at W52 | 14 mmHg |
Secondary
Measure of the Optical Coherence Tomography(OCT) Outcomes
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
Population: The database in OCT was corrupted and the data was lost
Secondary
Number of Participants With Need for Additional IOP Lowering Medications
Comparison between groups A and B for the need of additional IOP lowering medications
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aflibercept With Laser | Number of Participants With Need for Additional IOP Lowering Medications | 0 participants |
| Aflibercept | Number of Participants With Need for Additional IOP Lowering Medications | 0 participants |
Secondary
Number of Patients in Each, Group A and Group B, Gaining > 5 Letters on Visual Acuity
Comparison of patients in each, group A and group B, that gained \> 5 letters on visual acuity
Time frame: Baseline to Week 52
Population: One participant from group Aflibercept with Laser did not complete analysis due to death. Analysis is limited due to small sample size.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aflibercept With Laser | Number of Patients in Each, Group A and Group B, Gaining > 5 Letters on Visual Acuity | 2 participants |
| Aflibercept | Number of Patients in Each, Group A and Group B, Gaining > 5 Letters on Visual Acuity | 0 participants |
Secondary
Number of Patients Losing > 5 Letters on Visual Acuity in Each Group A and Group B
Comparison between patients, groups A and B, that lost \> 5 letters on visual acuity
Time frame: Baseline to Week 52
Population: One participant from group Aflibercept with Laser did not complete analysis due to death. Analysis is limited due to small sample size.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aflibercept With Laser | Number of Patients Losing > 5 Letters on Visual Acuity in Each Group A and Group B | 0 participants |
| Aflibercept | Number of Patients Losing > 5 Letters on Visual Acuity in Each Group A and Group B | 0 participants |
Secondary
Number of Patients With Need for Surgical Intervention
Comparison between groups A and B and the need for surgical intervention in both arms during the follow-up period
Time frame: 1 year
Population: One participant from group Aflibercept with Laser did not complete analysis due to death. Analysis is limited due to small sample size.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aflibercept With Laser | Number of Patients With Need for Surgical Intervention | 0 participants |
| Aflibercept | Number of Patients With Need for Surgical Intervention | 0 participants |
Secondary
Rate and Extent of Resolution of Neovascularization
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
Population: No data was collected or analyzed for this Outcome Measure
Secondary
Visual Acuity at Baseline
Comparison of visual acuity between groups A and B
Time frame: Baseline
Population: One participant from group Aflibercept with Laser did not complete analysis due to death. Analysis is limited due to small sample size.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Aflibercept With Laser | Visual Acuity at Baseline | 64 Letters |
| Aflibercept | Visual Acuity at Baseline | 37.5 Letters |
Secondary
Visual Acuity at Week 52
Comparison of visual acuity at Week 52 between groups A and B
Time frame: Week 52
Population: One participant from group Aflibercept with Laser did not complete analysis due to death. Analysis is limited due to small sample size.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Aflibercept With Laser | Visual Acuity at Week 52 | Study Eye Mean W52 Number of ETDRS Letters | 33.5 Letters |
| Aflibercept With Laser | Visual Acuity at Week 52 | Fellow Eye Mean W52 Number of ETDRS Letters | 32 Letters |
| Aflibercept | Visual Acuity at Week 52 | Study Eye Mean W52 Number of ETDRS Letters | 62 Letters |
| Aflibercept | Visual Acuity at Week 52 | Fellow Eye Mean W52 Number of ETDRS Letters | 46.75 Letters |