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ESBA1008 Safety, Tolerability and Effects in Wet Age-Related Macular Degeneration (AMD) Patients

Exudative Age-Related Macular Degeneration Clinical Trial

Official title:
Safety and Efficacy Study of ESBA1008 Versus LUCENTIS® for the Treatment of Exudative Age-Related Macular Degeneration

Clinical Trial Summary

The purpose of this study was to assess the safety, tolerability, and the effects of treatment on ocular outcomes following a single intravitreal administration of ESBA1008 compared with LUCENTIS® in patients with exudative age-related macular degeneration (AMD).

Clinical Trial Description

This study was conducted in two parts. In Part 1, patients were initially randomized (5:2) to receive either ESBA1008 at the lowest dose (Dose A) or LUCENTIS. After Safety Committee review, a second cohort was enrolled and randomized (5:2) to the next higher dose of ESBA1008 (Dose B). Safety review and enrollment of patients into the third cohort (Dose C) and fourth cohort (Dose D) was conducted in the same manner. Part 2, the expansion period, consisted of 2 arms. In the first arm patients were randomized to receive ESBA1008 Dose C or LUCENTIS (43:44) . In the second arm, patients were randomized to ESBA1008 Doses A:B:D:Lucentis (5:30:35:9). All enrolled patients (Part 1 and Part 2) were evaluated for safety and efficacy across 13 study visits, including Screening, Randomization, and 11 post- treatment follow-up visits (Day 1 through Month 6). ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01304693
Study type Interventional
Source Alcon Research
Contact
Status Completed
Phase Phase 1/Phase 2
Start date October 2010
Completion date March 2013
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