Phase 3
Completed N=10
Efficacy of an Intravitreal DEX Implant in Retinal Vein Occlusion Following Treatment With Anti-VEGF Injections.
Source: ClinicalTrials.gov NCT01449682 ↗Enrolled (actual)
10
Serious AEs
10.0%
Results posted
May 2017
Primary outcomePrimary: Macular Function Using Microperimetry — 2.7; 12.7; 4.2; 10.7 dB
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
To test the efficacy of a 0.7 mg intravitreal dexamethasone implant (Ozurdex®) on macular function and recalcitrant macular edema associated with retinal vein occlusion following treatment with 2 or more prior intravitreal anti-VEGF drug injections.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Macular Function Using Microperimetry |
2.7; 12.7; 4.2; 10.7 | — |
| PRIMARY Macular Function Using Multi-focal ERG |
3.61; 6.62; 18.20; 30.18 | — |
| SECONDARY To Determine if There is a Change in Visual Acuity (Number of ETDRS Letters) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups |
46.4; 55.6; 27.8; 53.2 | — |
| SECONDARY To Determine if There is a Change in Central Foveal Thickness (Microns on High Resolution OCT) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups |
501.7; 353.5; 361.4; 326.7 | — |
Eligibility Criteria
Inclusion Criteria
- Presence of central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO)
- Prior treatment with >= 2 intravitreal anti-VEGF injections but no treatment in last 45 days.
- Age 18 years or older
- ETDRS Visual acuity between 3 and 72 letters and approximate Snellen equivalent of 20/25 to 20/800
- Central foveal thickness >275 microns or presence of cystic edema on OCT studies.
- For sexually active women of childbearing potential, agreement to the use of an appropriate form of contraception (or abstinence) for the duration of the study.
- Ability to provide written informed consent • Capable of complying with study protocol
Exclusion Criteria
- History of steroid-related glaucoma (steroid response) requiring more than one topical glaucoma medication.
- Intraocular injection of steroid medication within prior 4 months
- Evidence of significant retinal ischemia on fluorescein angiography in the opinion of the treating physician.
- Previous laser photocoagulation within 4 months of study
- Concurrent ocular disease (e.g proliferative diabetic retinopathy, geographic atrophy) that would limit visual acuity in the opinion of the treating physician
- Patients who are pregnant.
- Unwilling or unable to follow or comply with all study related procedures.
Data sourced from ClinicalTrials.gov (NCT01449682). 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. Informational only — not medical advice.