Phase 2
Completed N=243
Safety and Efficacy of a New Treatment as Adjunctive Therapy to Anti-vascular Endothelial Growth Factor (Anti-VEGF) Treatment in Patients With Age-Related Macular Degeneration (AMD)
Choroidal Neovascularization · Age-Related Maculopathy
Source: ClinicalTrials.gov NCT00511706 ↗
Enrolled (actual)
243
Serious AEs
9.6%
Results posted
Sep 2012
Primary outcomePrimary: Injection Free Interval — 34; 29 Days
Summary
The study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with Anti-VEGF treatment vs. Anti-VEGF alone (with sham dexamethasone injection) in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Injection Free Interval |
34; 29 | — |
| SECONDARY Change From Baseline in the Best Corrected Visual Acuity (BCVA) at Week 25 |
55.5; 58.1; 2.0; 2.4 | — |
| SECONDARY Change From Baseline in the Mean Central Retinal Subfield Thickness at Week 25 as Assessed by Optical Coherence Tomography (OCT) in the Study Eye |
260.28; 272.45; -7.12; -13.00 | — |
| SECONDARY Change From Screening in the Area of Leakage From Choroidal Neovascularization (CNV) at Week 25 as Assessed by Fluorescein Angiography in the Study Eye |
8.44; 8.12; -2.32; -1.73 | — |
Eligibility Criteria
Inclusion Criteria
- 50 years of age or older with subfoveal choroidal neovascularization (CNV) (classic and/or occult) secondary to AMD
- Visual Acuity between 20/40 and 20/400 in the study eye
Exclusion Criteria
- Any intraocular surgery within 3 months
- Glaucoma
- Cataract
- High eye pressure
- Uncontrolled systemic disease
Data sourced from ClinicalTrials.gov (NCT00511706). 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.