Safety and Efficacy of ATG003 in Patients With AMD Receiving Anti-VEGF

CoMentis60 enrolled

Overview

This study is a double-masked, randomized, placebo-controlled study of the safety and preliminary efficacy of ATG003 (topical mecamylamine) in patients receiving maintenance injections of either ranibizumab or bevacizumab. Study Hypothesis: Mecamylamine could be effective in the treatment of neovascular AMD.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Age-Related Macular Degeneration

Interventions

ATG003 (mecamylamine)DRUG

1% Ophthalmic solution, eyedrop BID, 48 weeks

PlaceboDRUG

Placebo eyedrops, BID, 48 weeks

Eligibility

Sex: ALLMin age: 56 Years

Medical Language ↔ Plain English

Inclusion Criteria: * \> 55 years of age * clinical diagnosis of neovascular AMD Exclusion Criteria: * confounding ocular condition

Outcomes

Primary Outcomes

To evaluate the safety of ATG003 (mecamylamine HCL ophthalmic solution)

Time frame: Day 1 - Week 50

Secondary Outcomes

To evaluate the efficacy of ATG003

Time frame: Day 1 - Week 50

Data from ClinicalTrials.gov

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