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

October 26, 2010 updated by: CoMentis

A Phase II Randomized, Double-Masked, Study Comparing the Safety and Efficacy of ATG003 in Patients With Neovascular ("Wet") Age-Related Macular Degeneration (NV-AMD)

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

343

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Araraquara, Brazil
        • Hospital de Olhos de Araraquara
      • Belo Horizonte, Brazil
        • Centro Brasileiro de Ciências Visuais
      • Belo Horizonte, Brazil
        • Instituto da Visão
      • Goiânia, Brazil
        • Centro Brasileiro de Cirurgia dos Olhos
      • Porto Alegre, Brazil
        • Hospital de Clínicas de Porto Alegre
      • Rio de Janeiro, Brazil
        • Hospital Universitario Clementino Fraga Filho
      • São Paulo, Brazil
        • Clinica de Olhos Dr. Suel Abujamra
      • São Paulo, Brazil
        • Hospital das Clinicas Faculdade de Medicina da Universidade de São Paulo
      • São Paulo, Brazil
        • Hospital de Olhos de São Paulo
      • São Paulo, Brazil
        • Hospital São Paulo - Setor de Pesquisa Clínica
  • Czech Republic
      • Brno, Czech Republic
        • University Hospital Brno, Department of Ophthalmology
      • Hradec Kralove, Czech Republic
        • Eye Clinic University Hospital
      • Litomyšl, Czech Republic
        • Ophthalmology Nemocnice Litomysl
      • Olomouc, Czech Republic
        • University Hospital Olomouc, Department of Ophthalmology
      • Prague, Czech Republic
        • Faculty Hospital Kralovske Vinohrady, Dept. of Ophthalmology
      • Praha, Czech Republic
        • Cornea Lexum Praha
  • Mexico
      • CP, Mexico
        • Cif Biotec
      • CP, Mexico
        • Hospital Conde de Valenciana
      • Delegación Cuauhtémoc, Mexico
        • Fundación Hospital "Nuestra Sra de la Luz" I.A.P.
      • Mexico City, Mexico
        • Hospital General de Mexico
      • Mexico City, Mexico
        • Asociación para Evitar la Ceguera
      • Monterrey, Mexico
        • Hospital San Jose Tec de Monterrey
  • Poland
      • Gdansk, Poland
        • Klinika Chorob Oczu
      • Katowice, Poland
        • Oddział Okulistyczny Okręgowy Szpital Kolejowy
      • Lodz, Poland
        • Klinika Okulistyczna
      • Poznań, Poland
        • Oddział Okulistyki, Samodzielny Publiczny Szpital Kliniczny Nr 1 Przemienienia Pańskiego AM w Poznaniu
      • Warsaw, Poland
        • Katedra i Klinika Okulistyki, Samodzielny Publiczny Kliniczny Szpital Okulistyczny
      • Wrocław, Poland
        • Katedra i Klinika Okulistyki, Akademia Medyczna we Wrocławiu
  • Russian Federation
      • Kazan, Russian Federation
        • Republican Ophthalmologic Hospital of MH of Republic of Tatarstan
      • Moscow, Russian Federation
        • IRTC "Eye Microsurgery" n. a. S.N. Fyodorov
      • Moscow, Russian Federation
        • Moscow Scientific Research Institute of Eye Diseases
      • Rostov-on Don, Russian Federation
        • CJSC "Inter Yuna"
      • St. Petersburg, Russian Federation
        • City Consultative Diagnostic Centre # 1 (St. Petersburg)
      • St. Petersburg, Russian Federation
        • IRTC "Eye Microsurgery" n. a. S.N. Fyodorov
      • St. Petersburg, Russian Federation
        • Military Medical Academy n.a. S.M.Kirov of Ministry of Defence
      • St. Petersburg, Russian Federation
        • St. Petersburg State Medical University n. a. Pavlov
  • Ukraine
      • Kyiv, Ukraine
        • Kyiv City Centre of Eye Vascular and Endocrine Diseases of Organ of Vision
      • Kyiv, Ukraine
        • Kyiv City Ophthalmologic Hospital "Eye Microsurgery Centre"
      • Kyiv, Ukraine
        • Kyiv City Ophthalmologic Hospital
      • Odessa, Ukraine
        • V.P. Filatov Institute of Eye Diseases and Tissue Pathology of AMS of Ukraine
      • Odessa, Ukraine
        • Zaporizhzhya Center of Vision Rehabilitation
      • Simferopol, Ukraine
        • S.I. Georgiyevsky Crimean State Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Active Comparator: 1% mecamylamine
Drug: Mecamylamine
Active Comparator: 0.3% mecamylamine
Drug: Mecamylamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of Subjects Losing Fewer Than 15 ETDRS Letters of Visual Acuity at 48 Weeks Compared to Baseline.
Time Frame: Baseline to Week 48
Baseline to Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CoMentis

Investigators

  • Study Director: Carl Grove, CoMentis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

December 19, 2006

First Submitted That Met QC Criteria

December 20, 2006

First Posted (Estimate)

December 21, 2006

Study Record Updates

Last Update Posted (Estimate)

November 23, 2010

Last Update Submitted That Met QC Criteria

October 26, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATG003-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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