Safety and Efficacy of ATG003 in Patients With Wet Age-Related Macular Degeneration (AMD)

NCT ID: NCT00414206

Last Updated: 2010-11-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

343 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2009-09-30

Brief Summary

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This is a Phase II randomized, double-masked study comparing the safety and efficacy of ATG003 (mecamylamine HCl) 1.0% and 0.3% ophthalmic solutions to placebo in patients with neovascular ("wet") age-related macular degeneration (NV-AMD).

Detailed Description

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Conditions

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Macular Degeneration

Keywords

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AMD Wet AMD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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1% mecamylamine

Group Type ACTIVE_COMPARATOR

Mecamylamine

Intervention Type DRUG

0.3% mecamylamine

Group Type ACTIVE_COMPARATOR

Mecamylamine

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Mecamylamine

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Minimum Eligible Age

50 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

Role: STUDY_DIRECTOR

CoMentis

Locations

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Hospital de Olhos de Araraquara

Araraquara, , Brazil

Site Status

Centro Brasileiro de Ciências Visuais

Belo Horizonte, , Brazil

Site Status

Instituto da Visão

Belo Horizonte, , Brazil

Site Status

Centro Brasileiro de Cirurgia dos Olhos

Goiânia, , Brazil

Site Status

Hospital de Clinicas de Porto Alegre

Porto Alegre, , Brazil

Site Status

Hospital Universitário Clementino Fraga Filho

Rio de Janeiro, , Brazil

Site Status

Clínica de Olhos Dr. Suel Abujamra

São Paulo, , Brazil

Site Status

Hospital das Clínicas Faculdade de Medicina da Universidade de São Paulo

São Paulo, , Brazil

Site Status

Hospital de Olhos de São Paulo

São Paulo, , Brazil

Site Status

Hospital São Paulo - Setor de Pesquisa Clínica

São Paulo, , Brazil

Site Status

University Hospital Brno, Department of Ophthalmology

Brno, , Czechia

Site Status

Eye Clinic University Hospital

Hradec Králové, , Czechia

Site Status

Ophthalmology Nemocnice Litomysl

Litomyšl, , Czechia

Site Status

University Hospital Olomouc, Department of Ophthalmology

Olomouc, , Czechia

Site Status

Cornea Lexum Praha

Prague, , Czechia

Site Status

Faculty Hospital Kralovske Vinohrady, Dept. of Ophthalmology

Prague, , Czechia

Site Status

Cif Biotec

CP, , Mexico

Site Status

Hospital Conde de Valenciana

CP, , Mexico

Site Status

Fundación Hospital "Nuestra Sra de la Luz" I.A.P.

Delegación Cuauhtémoc, , Mexico

Site Status

Asociación Para Evitar la Ceguera

Mexico City, , Mexico

Site Status

Hospital General de México

Mexico City, , Mexico

Site Status

Hospital San José Tec de Monterrey

Monterrey, , Mexico

Site Status

Klinika Chorób Oczu

Gdansk, , Poland

Site Status

Oddział Okulistyczny Okręgowy Szpital Kolejowy

Katowice, , Poland

Site Status

Klinika Okulistyczna

Lodz, , Poland

Site Status

Oddział Okulistyki, Samodzielny Publiczny Szpital Kliniczny Nr 1 Przemienienia Pańskiego AM w Poznaniu

Poznan, , Poland

Site Status

Katedra i Klinika Okulistyki, Samodzielny Publiczny Kliniczny Szpital Okulistyczny

Warsaw, , Poland

Site Status

Katedra i Klinika Okulistyki, Akademia Medyczna we Wrocławiu

Wroclaw, , Poland

Site Status

Republican Ophthalmologic Hospital of MH of Republic of Tatarstan

Kazan', , Russia

Site Status

IRTC "Eye Microsurgery" n. a. S.N. Fyodorov

Moscow, , Russia

Site Status

Moscow Scientific Research Institute of Eye Diseases

Moscow, , Russia

Site Status

CJSC "Inter Yuna"

Rostov-on-Don, , Russia

Site Status

City Consultative Diagnostic Centre # 1 (St. Petersburg)

Saint Petersburg, , Russia

Site Status

IRTC "Eye Microsurgery" n. a. S.N. Fyodorov

Saint Petersburg, , Russia

Site Status

Military Medical Academy n.a. S.M.Kirov of Ministry of Defence

Saint Petersburg, , Russia

Site Status

St. Petersburg State Medical University n. a. Pavlov

Saint Petersburg, , Russia

Site Status

Kyiv City Centre of Eye Vascular and Endocrine Diseases of Organ of Vision

Kyiv, , Ukraine

Site Status

Kyiv City Ophthalmologic Hospital "Eye Microsurgery Centre"

Kyiv, , Ukraine

Site Status

Kyiv City Ophthalmologic Hospital

Kyiv, , Ukraine

Site Status

V.P. Filatov Institute of Eye Diseases and Tissue Pathology of AMS of Ukraine

Odesa, , Ukraine

Site Status

Zaporizhzhya Center of Vision Rehabilitation

Odesa, , Ukraine

Site Status

S.I. Georgiyevsky Crimean State Medical University

Simferopol, , Ukraine

Site Status

Countries

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Brazil Czechia Mexico Poland Russia Ukraine

Related Links

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Other Identifiers

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ATG003-201

Identifier Type: -

Identifier Source: org_study_id