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

NCT ID: NCT00607750

Last Updated: 2010-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Age-Related Macular Degeneration

Keywords

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Wet AMD, Comentis, ATG003, mecamylamine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo eyedrops, BID, 48 weeks

ATG003

Group Type EXPERIMENTAL

ATG003 (mecamylamine)

Intervention Type DRUG

1% Ophthalmic solution, eyedrop BID, 48 weeks

Interventions

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ATG003 (mecamylamine)

1% Ophthalmic solution, eyedrop BID, 48 weeks

Intervention Type DRUG

Placebo

Placebo eyedrops, BID, 48 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* \> 55 years of age
* clinical diagnosis of neovascular AMD

Exclusion Criteria

* confounding ocular condition
Minimum Eligible Age

56 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CoMentis

INDUSTRY

Sponsor Role lead

Responsible Party

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CoMentis, Inc.

Principal Investigators

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Carl Grove, MS

Role: STUDY_DIRECTOR

Comentis, Inc.

Countries

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United States

Other Identifiers

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ATG003-203

Identifier Type: -

Identifier Source: org_study_id