Proliferative Diabetic Retinopathy, Vitreous Hemorrhage
Conditions
Keywords
Anti-VEGF, Vitrectomy
Brief summary
Although vitreous hemorrhage (VH) from proliferative diabetic retinopathy (PDR) can cause acute and dramatic vision loss for patients with diabetes, there is no current, evidence-based clinical guidance as to what treatment method is most likely to provide the best visual outcomes once intervention is desired. Intravitreous anti-vascular endothelial growth factor (anti-VEGF) therapy alone or vitrectomy combined with intraoperative PRP each provide the opportunity to stabilize or regress retinal neovascularization. However, clinical trials are lacking to elucidate the relative time frame of visual recovery or final visual outcome in prompt vitrectomy compared with initial anti-VEGF treatment. The Diabetic Retinopathy Clinical Research Network Protocol N demonstrated short-term trends consistent with a possible beneficial effect of anti-VEGF treatment in eyes with VH from PDR, including greater visual acuity improvement and reduced rates of recurrent VH as compared with saline injection. It is possible that a study with a longer duration of follow-up with structured anti-VEGF retreatment would demonstrate even greater effectiveness of anti-VEGF for VH to avoid vitrectomy and its attendant adverse events while also improving visual acuity. On the other hand, advances in surgical techniques leading to faster operative times, quicker patient recovery, and reduced complication rates may make prompt vitrectomy a more attractive alternative since it results in the immediate ability to clear hemorrhage and to perform PRP if desired, often as part of one procedure. This proposed study will evaluate the safety and efficacy of two treatment approaches for eyes with VH from PDR: prompt vitrectomy + PRP and intravitreous aflibercept injections.
Detailed description
A participant could have only one eye enrolled in the study.
Interventions
DRUG2-mg Intravitreous Aflibercept Injection
Soluble decoy receptor fusion protein that has a high binding affinity to all isoforms of VEGF as well as to placental growth factor.
PROCEDUREPrompt Vitrectomy Plus Panretinal Photocoagulation
Surgical removal of the vitreous gel and associated hemorrhage, concurrent delivery of panretinal endolaser
Sponsors
National Institutes of Health (NIH)
Regeneron Pharmaceuticals
National Eye Institute (NEI)
Jaeb Center for Health Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \>= 18 years Participants \<18 years old are not being included because proliferative diabetic retinopathy is so rare in this age group that the diagnosis may be questionable. 2. Diagnosis of diabetes mellitus (type 1 or type 2) Any one of the following will be considered to be sufficient evidence that diabetes is present: * Current regular use of insulin for the treatment of diabetes * Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes * Documented diabetes by American Diabetes Association and/or World Health Organization criteria 4. Able and willing to provide informed consent. 5. Patient is willing and able to undergo vitrectomy within next 2 weeks and the vitrectomy can be scheduled within that time frame. 6\. Vitreous hemorrhage causing vision impairment, presumed to be from proliferative diabetic retinopathy, for which intervention is deemed necessary. * Note: Prior panretinal photocoagulation is neither a requirement nor an exclusion. * Subhyaloid hemorrhage alone does not make an eye eligible; however, presence of subhyaloid hemorrhage in addition to the criteria above will not preclude participation provided the investigator is comfortable with either treatment regimen. 7\. Immediate vitrectomy not required (investigator and participant are willing to wait at least 4 months to see if hemorrhage clears sufficiently with anti-vascular endothelial growth factor without having to proceed to vitrectomy). 8\. Visual acuity letter score ≤78 (approximate Snellen equivalent 20/32) and at least light perception. 9\. Investigators should use particular caution when considering enrollment of an eye with visual acuity letter score 69 to 78 (approximate Snellen equivalent 20/32 to 20/40) to ensure that the need for vitrectomy and its potential benefits outweigh the potential risks.
Exclusion criteria
* A potential participant is not eligible if any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| E-ETDRS Visual Acuity Letter Score (Area Under the Curve From Baseline) | 24 weeks | The area under the curve (units = letters·weeks) was divided by 24 weeks (units = weeks) to obtain an average change in letter score (units = letters) over the 24-weekr follow-up. Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent of \<20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| E-ETDRS Visual Acuity Letter Score | 4 Weeks | Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent \<20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity. |
| E-ETDRS Visual Acuity Letter Score (Area Under the Curve From Baseline) | 2-Years | Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent \<20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity. The area under the curve (units = letters·years) was divided by 2 years (units = years) to obtain an average change in letter score (units = letters) over the 2-year follow-up. Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent of \<20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity. |
| Snellen Equivalent Range (Visual Acuity Score) | 4 weeks | Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent \<20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity. |
| Recurrent Vitreous Hemorrhage | At any time through 2 years | Assessed by the investigator and defined as presence of vitreous hemorrhage after a period of absence. Excludes eyes in which vitreous hemorrhage could not be assessed during follow-up. |
| Retinal Neovascularization on Clinical Exam | 24 weeks | Defined as neovascularization of the disc or elsewhere. Excludes eyes in which retinal neovascularization could not be determined. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intravitreous 2 mg Aflibercept Injections Initial injection must be given on the day of randomization. Follow-up injections will be performed as often as every 4 weeks unless criteria for deferral are met.
2-mg Intravitreous Aflibercept Injection: Soluble decoy receptor fusion protein that has a high binding affinity to all isoforms of VEGF as well as to placental growth factor. | 100 |
| Prompt Vitrectomy Plus Panretinal Photocoagulation For the prompt vitrectomy + panretinal photocoagulation group, the vitrectomy must be scheduled to be performed within 2 weeks of randomization. Vitrectomy will be performed according to the investigator's usual routine, including pre-operative care, surgical procedure, and post-operative care, although anti-VEGF may not be given post-operatively unless there is recurrent hemorrhage.
Prompt Vitrectomy Plus Panretinal Photocoagulation: Surgical removal of the vitreous gel and associated hemorrhage, concurrent delivery of panretinal endolaser | 105 |
| Total | 205 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Completed Out of Window | 1 | 3 |
| Overall Study | Death | 6 | 3 |
| Overall Study | Lost to Follow-up | 2 | 7 |
| Overall Study | Withdrawal by Subject | 1 | 5 |
Baseline characteristics
| Characteristic | Intravitreous 2 mg Aflibercept Injections | Prompt Vitrectomy Plus Panretinal Photocoagulation | Total |
|---|---|---|---|
| Age, Continuous | 56 years STANDARD_DEVIATION 12 | 57 years STANDARD_DEVIATION 11 | 57 years STANDARD_DEVIATION 11 |
| Approximate Duration of Vitreous Hemorrhage 1 to 3 Months | 27 Eyes | 27 Eyes | 54 Eyes |
| Approximate Duration of Vitreous Hemorrhage 4 to 6 Months | 8 Eyes | 6 Eyes | 14 Eyes |
| Approximate Duration of Vitreous Hemorrhage 7 to 12 Months | 1 Eyes | 6 Eyes | 7 Eyes |
| Approximate Duration of Vitreous Hemorrhage Less than 1 Month | 60 Eyes | 57 Eyes | 117 Eyes |
| Approximate Duration of Vitreous Hemorrhage More than 12 Months | 4 Eyes | 9 Eyes | 13 Eyes |
| Body Mass Index | 31 kg/m^2 STANDARD_DEVIATION 7 | 32 kg/m^2 STANDARD_DEVIATION 7 | 31 kg/m^2 STANDARD_DEVIATION 7 |
| Daily Cigarette Smoking Current | 13 Participants | 8 Participants | 21 Participants |
| Daily Cigarette Smoking Never | 60 Participants | 72 Participants | 132 Participants |
| Daily Cigarette Smoking Prior | 27 Participants | 25 Participants | 52 Participants |
| Diabetes Type Type 1 | 17 Participants | 19 Participants | 36 Participants |
| Diabetes Type Type 2 | 83 Participants | 86 Participants | 169 Participants |
| Duration of Diabetes | 19 years STANDARD_DEVIATION 10 | 21 years STANDARD_DEVIATION 11 | 20 years STANDARD_DEVIATION 11 |
| E-ETDRS visual acuity letter score | 35.6 units on a scale STANDARD_DEVIATION 28.1 | 33.5 units on a scale STANDARD_DEVIATION 28.8 | 34.5 units on a scale STANDARD_DEVIATION 28.4 |
| Hemoglobin A1c | 8.7 Hemoglobin A1c percentage STANDARD_DEVIATION 2.2 | 8.3 Hemoglobin A1c percentage STANDARD_DEVIATION 1.9 | 8.5 Hemoglobin A1c percentage STANDARD_DEVIATION 2 |
| Insulin Used No | 22 Participants | 27 Participants | 49 Participants |
| Insulin Used Yes | 78 Participants | 78 Participants | 156 Participants |
| Intraocular Pressure | 16 mmHg STANDARD_DEVIATION 4 | 15 mmHg STANDARD_DEVIATION 3 | 15 mmHg STANDARD_DEVIATION 4 |
| Kidney Disease | 20 Participants | 18 Participants | 38 Participants |
| Lens Status on Clinical Exam Phakic (natural lens) | 75 Eyes | 81 Eyes | 156 Eyes |
| Lens Status on Clinical Exam Prosthetic intraocular lens | 25 Eyes | 24 Eyes | 49 Eyes |
| Mean Arterial Blood Pressure | 102 mmHg STANDARD_DEVIATION 12 | 102 mmHg STANDARD_DEVIATION 12 | 102 mmHg STANDARD_DEVIATION 12 |
| Prior anti-vascular endothelial growth factor for diabetic macular edema | 23 Eyes | 28 Eyes | 51 Eyes |
| Prior anti-vascular endothelial growth factor for diabetic retinopathy | 23 Eyes | 22 Eyes | 45 Eyes |
| Prior focal/grid laser for Diabetic Macular Edema | 15 Eyes | 16 Eyes | 31 Eyes |
| Prior Myocardial Infarction | 7 Participants | 15 Participants | 22 Participants |
| Prior panretinal photocoagulation | 42 Eyes | 58 Eyes | 100 Eyes |
| Prior Stroke | 5 Participants | 8 Participants | 13 Participants |
| Prior Treatment for Diabetic Macular Edema | 29 Eyes | 37 Eyes | 66 Eyes |
| Race/Ethnicity, Customized American Indian/Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 5 Participants | 7 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 43 Participants | 41 Participants | 84 Participants |
| Race/Ethnicity, Customized More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black/African American | 16 Participants | 11 Participants | 27 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 36 Participants | 47 Participants | 83 Participants |
| Race/Ethnicity, Customized Unknown or not reported | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment United States | 100 participants | 105 participants | 205 participants |
| Sex: Female, Male Female | 47 Participants | 43 Participants | 90 Participants |
| Sex: Female, Male Male | 53 Participants | 62 Participants | 115 Participants |
| Traction Retinal Detachment, Macula Not Threatened | 5 Eyes | 3 Eyes | 8 Eyes |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 100 | 3 / 105 |
| other Total, other adverse events | 97 / 100 | 98 / 105 |
| serious Total, serious adverse events | 44 / 100 | 45 / 105 |
Outcome results
Primary
E-ETDRS Visual Acuity Letter Score (Area Under the Curve From Baseline)
The area under the curve (units = letters·weeks) was divided by 24 weeks (units = weeks) to obtain an average change in letter score (units = letters) over the 24-weekr follow-up. Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent of \<20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravitreous 2 mg Aflibercept Injections | E-ETDRS Visual Acuity Letter Score (Area Under the Curve From Baseline) | 59.3 units on a scale | Standard Deviation 21.9 |
| Prompt Vitrectomy Plus Panretinal Photocoagulation | E-ETDRS Visual Acuity Letter Score (Area Under the Curve From Baseline) | 63.0 units on a scale | Standard Deviation 21.7 |
Secondary
E-ETDRS Visual Acuity Letter Score
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent \<20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
Time frame: 4 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravitreous 2 mg Aflibercept Injections | E-ETDRS Visual Acuity Letter Score | 52.6 units on a scale | Standard Deviation 29.4 |
| Prompt Vitrectomy Plus Panretinal Photocoagulation | E-ETDRS Visual Acuity Letter Score | 62.3 units on a scale | Standard Deviation 26.8 |
Secondary
E-ETDRS Visual Acuity Letter Score
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent \<20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
Time frame: 12 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravitreous 2 mg Aflibercept Injections | E-ETDRS Visual Acuity Letter Score | 63.7 units on a scale | Standard Deviation 25 |
| Prompt Vitrectomy Plus Panretinal Photocoagulation | E-ETDRS Visual Acuity Letter Score | 67.3 units on a scale | Standard Deviation 24.7 |
Secondary
E-ETDRS Visual Acuity Letter Score
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent \<20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
Time frame: 24 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravitreous 2 mg Aflibercept Injections | E-ETDRS Visual Acuity Letter Score | 69.4 units on a scale | Standard Deviation 23.8 |
| Prompt Vitrectomy Plus Panretinal Photocoagulation | E-ETDRS Visual Acuity Letter Score | 69.0 units on a scale | Standard Deviation 23.1 |
Secondary
E-ETDRS Visual Acuity Letter Score
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent \<20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
Time frame: 2 Years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravitreous 2 mg Aflibercept Injections | E-ETDRS Visual Acuity Letter Score | 73.7 units on a scale | Standard Deviation 16.4 |
| Prompt Vitrectomy Plus Panretinal Photocoagulation | E-ETDRS Visual Acuity Letter Score | 71.0 units on a scale | Standard Deviation 24 |
Secondary
E-ETDRS Visual Acuity Letter Score
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent \<20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
Time frame: 1-Year from participant randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravitreous 2 mg Aflibercept Injections | E-ETDRS Visual Acuity Letter Score | 70.5 units on a scale | Standard Deviation 20.3 |
| Prompt Vitrectomy Plus Panretinal Photocoagulation | E-ETDRS Visual Acuity Letter Score | 72.7 units on a scale | Standard Deviation 20.3 |
Secondary
E-ETDRS Visual Acuity Letter Score (Area Under the Curve From Baseline)
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent \<20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity. The area under the curve (units = letters·years) was divided by 2 years (units = years) to obtain an average change in letter score (units = letters) over the 2-year follow-up. Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent of \<20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
Time frame: 2-Years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravitreous 2 mg Aflibercept Injections | E-ETDRS Visual Acuity Letter Score (Area Under the Curve From Baseline) | 68.7 units on a scale | Standard Deviation 15 |
| Prompt Vitrectomy Plus Panretinal Photocoagulation | E-ETDRS Visual Acuity Letter Score (Area Under the Curve From Baseline) | 70.0 units on a scale | Standard Deviation 18.8 |
Secondary
Recurrent Vitreous Hemorrhage
Assessed by the investigator and defined as presence of vitreous hemorrhage after a period of absence. Excludes eyes in which vitreous hemorrhage could not be assessed during follow-up.
Time frame: At any time through 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intravitreous 2 mg Aflibercept Injections | Recurrent Vitreous Hemorrhage | 48 Participants |
| Prompt Vitrectomy Plus Panretinal Photocoagulation | Recurrent Vitreous Hemorrhage | 16 Participants |
Secondary
Retinal Neovascularization on Clinical Exam
Defined as neovascularization of the disc or elsewhere. Excludes eyes in which retinal neovascularization could not be determined
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intravitreous 2 mg Aflibercept Injections | Retinal Neovascularization on Clinical Exam | 20 Participants |
| Prompt Vitrectomy Plus Panretinal Photocoagulation | Retinal Neovascularization on Clinical Exam | 2 Participants |
Secondary
Retinal Neovascularization on Clinical Exam
Defined as neovascularization of the disc or elsewhere. Excludes eyes in which retinal neovascularization could not be determined.
Time frame: 24 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intravitreous 2 mg Aflibercept Injections | Retinal Neovascularization on Clinical Exam | 25 Participants |
| Prompt Vitrectomy Plus Panretinal Photocoagulation | Retinal Neovascularization on Clinical Exam | 3 Participants |
Secondary
Retinal Neovascularization on Clinical Exam
Defined as neovascularization of the disc or elsewhere. Excludes eyes in which retinal neovascularization could not be determined
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intravitreous 2 mg Aflibercept Injections | Retinal Neovascularization on Clinical Exam | 15 Participants |
| Prompt Vitrectomy Plus Panretinal Photocoagulation | Retinal Neovascularization on Clinical Exam | 2 Participants |
Secondary
Snellen Equivalent Range (Visual Acuity Score)
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent \<20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity..
Time frame: 2 years
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intravitreous 2 mg Aflibercept Injections | Snellen Equivalent Range (Visual Acuity Score) | 20/32 or better (>=74 | 56 Participants |
| Intravitreous 2 mg Aflibercept Injections | Snellen Equivalent Range (Visual Acuity Score) | 20/200 or worse (<=38) | 3 Participants |
| Prompt Vitrectomy Plus Panretinal Photocoagulation | Snellen Equivalent Range (Visual Acuity Score) | 20/32 or better (>=74 | 59 Participants |
| Prompt Vitrectomy Plus Panretinal Photocoagulation | Snellen Equivalent Range (Visual Acuity Score) | 20/200 or worse (<=38) | 10 Participants |
Secondary
Snellen Equivalent Range (Visual Acuity Score)
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent \<20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
Time frame: 12 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intravitreous 2 mg Aflibercept Injections | Snellen Equivalent Range (Visual Acuity Score) | 20/32 or better (>=74 | 45 Participants |
| Intravitreous 2 mg Aflibercept Injections | Snellen Equivalent Range (Visual Acuity Score) | 20/200 or worse (<=38) | 16 Participants |
| Prompt Vitrectomy Plus Panretinal Photocoagulation | Snellen Equivalent Range (Visual Acuity Score) | 20/32 or better (>=74 | 58 Participants |
| Prompt Vitrectomy Plus Panretinal Photocoagulation | Snellen Equivalent Range (Visual Acuity Score) | 20/200 or worse (<=38) | 12 Participants |
Secondary
Snellen Equivalent Range (Visual Acuity Score)
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent \<20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
Time frame: 4 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intravitreous 2 mg Aflibercept Injections | Snellen Equivalent Range (Visual Acuity Score) | 20/32 or better (>=74) | 24 Participants |
| Intravitreous 2 mg Aflibercept Injections | Snellen Equivalent Range (Visual Acuity Score) | 20/200 or worse (<=38) | 26 Participants |
| Prompt Vitrectomy Plus Panretinal Photocoagulation | Snellen Equivalent Range (Visual Acuity Score) | 20/32 or better (>=74) | 49 Participants |
| Prompt Vitrectomy Plus Panretinal Photocoagulation | Snellen Equivalent Range (Visual Acuity Score) | 20/200 or worse (<=38) | 18 Participants |
Secondary
Snellen Equivalent Range (Visual Acuity Score)
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent \<20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
Time frame: 24 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intravitreous 2 mg Aflibercept Injections | Snellen Equivalent Range (Visual Acuity Score) | 20/32 or better (>=74 | 61 Participants |
| Intravitreous 2 mg Aflibercept Injections | Snellen Equivalent Range (Visual Acuity Score) | 20/200 or worse (<=38) | 10 Participants |
| Prompt Vitrectomy Plus Panretinal Photocoagulation | Snellen Equivalent Range (Visual Acuity Score) | 20/32 or better (>=74 | 59 Participants |
| Prompt Vitrectomy Plus Panretinal Photocoagulation | Snellen Equivalent Range (Visual Acuity Score) | 20/200 or worse (<=38) | 10 Participants |
Secondary
Snellen Equivalent Range (Visual Acuity Score)
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent \<20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
Time frame: 1 year
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intravitreous 2 mg Aflibercept Injections | Snellen Equivalent Range (Visual Acuity Score) | 20/32 or better (>=74 | 55 Participants |
| Intravitreous 2 mg Aflibercept Injections | Snellen Equivalent Range (Visual Acuity Score) | 20/200 or worse (<=38) | 8 Participants |
| Prompt Vitrectomy Plus Panretinal Photocoagulation | Snellen Equivalent Range (Visual Acuity Score) | 20/32 or better (>=74 | 65 Participants |
| Prompt Vitrectomy Plus Panretinal Photocoagulation | Snellen Equivalent Range (Visual Acuity Score) | 20/200 or worse (<=38) | 8 Participants |