Phase 4
N=20
Evaluation of Macugen Treatment of Macular Edema Due to Branch Retinal Vein Occlusion
Branch Retinal Vein Occlusion
Bottom Line
View on ClinicalTrials.gov: NCT00406107 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcome: Primary: Change in ETDRS Best Corrected Visual Acuity From Baseline at 54 Weeks — 14 ETDRS letters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- pegaptanib sodium (Macugen) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Palmetto Retina Center, LLC
- Primary completion
- Dec 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in ETDRS Best Corrected Visual Acuity From Baseline at 54 Weeks |
14 | — |
| SECONDARY Standardized Change From Baseline in Macular Thickening Measured by OCT3 Using the Central Point of the Central Subfield |
-205 | — |
| SECONDARY Safety Parameters |
6.67; 0 | — |
| SECONDARY Change in Central Subfield Thickness on OCT From Baseline to Week 54 |
-201 | — |
| SECONDARY Change in Macular Volume on OCT From Baseline to Week 54 |
-2.2 | — |
Summary
The purpose of this study is to evaluate the effect of intravitreal injections of Macugen every 6 weeks for the treatment of macular edema secondary to branch retinal vein occlusion (BRVO). We hypothesize that macular edema secondary to BRVO is mediated by VEGF 165 and that chronic suppression of VEGF 165 will successfully treat BRVO related macular edema.
Eligibility Criteria
Inclusion Criteria
- Macular edema secondary to BRVO involving the foveal center in male or female patients at least 18 years of age
- Duration of BRVO macular edema less than 6 months prior to baseline visit
- Best corrected ETDRS visual acuity 20/40-20/320 (Snellen equivalent) using the 4 meters testing method.
- Central foveal thickness greater than or equal to 250 microns using the OCT-3
- Less than 25% of foveal capillary ring disruption
- Less than 2 disc areas of capillary non-perfusion within 1000 microns of the foveal center
- Absence of hemorrhage or lipid in the foveal center
- Investigator comfortable deferring macular laser for 18 weeks from baseline and intravitreous steroid for 36 weeks from baseline
Exclusion Criteria
- Ocular conditions other than BRVO related macular edema such as significant cataract, diabetic retinopathy, AMD, glaucoma, uveitis, epiretinal membrane, vitreomacular traction or tumor.
- Intraocular surgery within past 3 months
- Significant enlargement of foveal avascular zone(>25% disruption of capillary ring) or greater than 2 disc areas of nonperfusion within 1000 microns of foveal center.
- Likelihood of evidence driven indication for peripheral photocoagulation in the next 6 months.
- Patients who have shown evidence of spontaneous improvement within the preceding 3 months, as determined by an improvement of >15 letters of vision or thinning of the Center Point on OCT of >20% from baseline determination
- Prior grid laser within 4 months of baseline or more than one prior grid laser treatment.
- No prior intravitreous or periocular steroid injections in the study eye.
Data sourced from ClinicalTrials.gov (NCT00406107). 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.