Phase 3
N=205
Anti-VEGF vs. Prompt Vitrectomy for VH From PDR
Proliferative Diabetic Retinopathy · Vitreous Hemorrhage
Bottom Line
View on ClinicalTrials.gov: NCT02858076 ↗Enrolled (actual)
205
Serious AEs
43.4%
Results posted
Jan 2021
Primary outcome: Primary: E-ETDRS Visual Acuity Letter Score (Area Under the Curve From Baseline) — 59.3; 63.0 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 2-mg Intravitreous Aflibercept Injection (Drug); Prompt Vitrectomy Plus Panretinal Photocoagulation (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Jaeb Center for Health Research
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY E-ETDRS Visual Acuity Letter Score (Area Under the Curve From Baseline) |
68.7; 70.0 | — |
| SECONDARY E-ETDRS Visual Acuity Letter Score |
73.7; 71.0 | — |
| SECONDARY E-ETDRS Visual Acuity Letter Score |
73.7; 71.0 | — |
| SECONDARY E-ETDRS Visual Acuity Letter Score |
73.7; 71.0 | — |
| SECONDARY E-ETDRS Visual Acuity Letter Score |
73.7; 71.0 | — |
| SECONDARY E-ETDRS Visual Acuity Letter Score |
73.7; 71.0 | — |
| SECONDARY E-ETDRS Visual Acuity Letter Score (Area Under the Curve From Baseline) |
68.7; 70.0 | — |
| SECONDARY Snellen Equivalent Range (Visual Acuity Score) |
56; 59; 3; 10 | — |
| SECONDARY Snellen Equivalent Range (Visual Acuity Score) |
56; 59; 3; 10 | — |
| SECONDARY Snellen Equivalent Range (Visual Acuity Score) |
56; 59; 3; 10 | — |
| SECONDARY Snellen Equivalent Range (Visual Acuity Score) |
56; 59; 3; 10 | — |
| SECONDARY Snellen Equivalent Range (Visual Acuity Score) |
56; 59; 3; 10 | — |
| SECONDARY Recurrent Vitreous Hemorrhage |
48; 16 | — |
| SECONDARY Retinal Neovascularization on Clinical Exam |
20; 2 | — |
| SECONDARY Retinal Neovascularization on Clinical Exam |
20; 2 | — |
| SECONDARY Retinal Neovascularization on Clinical Exam |
20; 2 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age >= 18 years Participants 180/110 (systolic above 180 or diastolic above 110).
- If blood pressure is brought below 180/110 by anti-hypertensive treatment, potential participant can become eligible.
- Systemic anti-vascular endothelial growth factor or pro-vascular endothelial growth factor treatment within 4 months prior to randomization.
- These drugs cannot be used during the study.
- For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next two years.
- Women who are potential participants should be questioned about the potential for pregnancy. Investigator judgment is used to determine when a pregnancy test is needed.
- Potential participant is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the two years.
- Evidence of traction detachment involving or threatening the macula.
- If the density of the hemorrhage precludes a visual assessment on clinical exam to confirm eligibility, then it is recommended that assessment be performed with ultrasound as standard care.
- Evidence of rhegmatogenous retinal detachment.
- If the density of the hemorrhage precludes a visual assessment on clinical exam to confirm eligibility, then it is recommended that assessment be performed with ultrasound as standard care.
- Evidence of neovascular glaucoma (iris or angle neovascularization is not an exclusion).
- Known diabetic macular edema (DME), defined as either
- Optical coherence tomography central subfield thickness (microns):
- Zeiss Cirrus: ≥290 in women; ≥305 in men
- Heidelberg Spectralis: ≥305 in women; ≥320 in men OR
- Diabetic macular edema on clinical exam that the investigator believes currently requires treatment.
- History of intravitreous anti-vascular endothelial growth factor treatment within 2 months prior to current vitreous hemorrhage onset or after onset.
- History of intraocular corticosteroid treatment within 4 months prior to current vitreous hemorrhage onset or after onset.
- 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 YAG 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.
Data sourced from ClinicalTrials.gov (NCT02858076). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.