Phase 2 N=243 Randomized Triple-blind Treatment

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

Bottom Line

View on ClinicalTrials.gov: NCT00511706 ↗

Enrolled (actual)

243

Serious AEs

9.6%

Results posted

Sep 2012

Primary outcome: Primary: Injection Free Interval — 34; 29 Days

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: dexamethasone (Drug); ranibizumab (Biological); sham (Other)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Allergan
Primary completion: Mar 2009

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	—

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.

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

View full record on ClinicalTrials.gov →

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.