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

Primary Purpose

Macular Degeneration

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Mecamylamine
Placebo
Sponsored by
CoMentis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration focused on measuring AMD, Wet AMD

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Sites / Locations

  • Hospital de Olhos de Araraquara
  • Centro Brasileiro de Ciências Visuais
  • Instituto da Visão
  • Centro Brasileiro de Cirurgia dos Olhos
  • Hospital de Clinicas de Porto Alegre
  • Hospital Universitário Clementino Fraga Filho
  • Clínica de Olhos Dr. Suel Abujamra
  • Hospital das Clínicas Faculdade de Medicina da Universidade de São Paulo
  • Hospital de Olhos de São Paulo
  • Hospital São Paulo - Setor de Pesquisa Clínica
  • University Hospital Brno, Department of Ophthalmology
  • Eye Clinic University Hospital
  • Ophthalmology Nemocnice Litomysl
  • University Hospital Olomouc, Department of Ophthalmology
  • Faculty Hospital Kralovske Vinohrady, Dept. of Ophthalmology
  • Cornea Lexum Praha
  • Cif Biotec
  • Hospital Conde de Valenciana
  • Fundación Hospital "Nuestra Sra de la Luz" I.A.P.
  • Asociación Para Evitar la Ceguera
  • Hospital General de México
  • Hospital San José Tec de Monterrey
  • Klinika Chorób Oczu
  • Oddział Okulistyczny Okręgowy Szpital Kolejowy
  • Klinika Okulistyczna
  • Oddział Okulistyki, Samodzielny Publiczny Szpital Kliniczny Nr 1 Przemienienia Pańskiego AM w Poznaniu
  • Katedra i Klinika Okulistyki, Samodzielny Publiczny Kliniczny Szpital Okulistyczny
  • Katedra i Klinika Okulistyki, Akademia Medyczna we Wrocławiu
  • Republican Ophthalmologic Hospital of MH of Republic of Tatarstan
  • IRTC "Eye Microsurgery" n. a. S.N. Fyodorov
  • Moscow Scientific Research Institute of Eye Diseases
  • CJSC "Inter Yuna"
  • City Consultative Diagnostic Centre # 1 (St. Petersburg)
  • IRTC "Eye Microsurgery" n. a. S.N. Fyodorov
  • Military Medical Academy n.a. S.M.Kirov of Ministry of Defence
  • St. Petersburg State Medical University n. a. Pavlov
  • Kyiv City Centre of Eye Vascular and Endocrine Diseases of Organ of Vision
  • Kyiv City Ophthalmologic Hospital "Eye Microsurgery Centre"
  • Kyiv City Ophthalmologic Hospital
  • V.P. Filatov Institute of Eye Diseases and Tissue Pathology of AMS of Ukraine
  • Zaporizhzhya Center of Vision Rehabilitation
  • S.I. Georgiyevsky Crimean State Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

1% mecamylamine

0.3% mecamylamine

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Proportion of Subjects Losing Fewer Than 15 ETDRS Letters of Visual Acuity at 48 Weeks Compared to Baseline.

Secondary Outcome Measures

Full Information

First Posted
December 19, 2006
Last Updated
October 26, 2010
Sponsor
CoMentis
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1. Study Identification

Unique Protocol Identification Number
NCT00414206
Brief Title
Safety and Efficacy of ATG003 in Patients With Wet Age-Related Macular Degeneration (AMD)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision
Study Start Date
March 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
CoMentis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
Keywords
AMD, Wet AMD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
343 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1% mecamylamine
Arm Type
Active Comparator
Arm Title
0.3% mecamylamine
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Mecamylamine
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Proportion of Subjects Losing Fewer Than 15 ETDRS Letters of Visual Acuity at 48 Weeks Compared to Baseline.
Time Frame
Baseline to Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl Grove
Organizational Affiliation
CoMentis
Official's Role
Study Director
Facility Information:
Facility Name
Hospital de Olhos de Araraquara
City
Araraquara
Country
Brazil
Facility Name
Centro Brasileiro de Ciências Visuais
City
Belo Horizonte
Country
Brazil
Facility Name
Instituto da Visão
City
Belo Horizonte
Country
Brazil
Facility Name
Centro Brasileiro de Cirurgia dos Olhos
City
Goiânia
Country
Brazil
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
Country
Brazil
Facility Name
Hospital Universitário Clementino Fraga Filho
City
Rio de Janeiro
Country
Brazil
Facility Name
Clínica de Olhos Dr. Suel Abujamra
City
São Paulo
Country
Brazil
Facility Name
Hospital das Clínicas Faculdade de Medicina da Universidade de São Paulo
City
São Paulo
Country
Brazil
Facility Name
Hospital de Olhos de São Paulo
City
São Paulo
Country
Brazil
Facility Name
Hospital São Paulo - Setor de Pesquisa Clínica
City
São Paulo
Country
Brazil
Facility Name
University Hospital Brno, Department of Ophthalmology
City
Brno
Country
Czech Republic
Facility Name
Eye Clinic University Hospital
City
Hradec Kralove
Country
Czech Republic
Facility Name
Ophthalmology Nemocnice Litomysl
City
Litomyšl
Country
Czech Republic
Facility Name
University Hospital Olomouc, Department of Ophthalmology
City
Olomouc
Country
Czech Republic
Facility Name
Faculty Hospital Kralovske Vinohrady, Dept. of Ophthalmology
City
Prague
Country
Czech Republic
Facility Name
Cornea Lexum Praha
City
Praha
Country
Czech Republic
Facility Name
Cif Biotec
City
CP
Country
Mexico
Facility Name
Hospital Conde de Valenciana
City
CP
Country
Mexico
Facility Name
Fundación Hospital "Nuestra Sra de la Luz" I.A.P.
City
Delegación Cuauhtémoc
Country
Mexico
Facility Name
Asociación Para Evitar la Ceguera
City
Mexico City
Country
Mexico
Facility Name
Hospital General de México
City
Mexico City
Country
Mexico
Facility Name
Hospital San José Tec de Monterrey
City
Monterrey
Country
Mexico
Facility Name
Klinika Chorób Oczu
City
Gdansk
Country
Poland
Facility Name
Oddział Okulistyczny Okręgowy Szpital Kolejowy
City
Katowice
Country
Poland
Facility Name
Klinika Okulistyczna
City
Lodz
Country
Poland
Facility Name
Oddział Okulistyki, Samodzielny Publiczny Szpital Kliniczny Nr 1 Przemienienia Pańskiego AM w Poznaniu
City
Poznań
Country
Poland
Facility Name
Katedra i Klinika Okulistyki, Samodzielny Publiczny Kliniczny Szpital Okulistyczny
City
Warsaw
Country
Poland
Facility Name
Katedra i Klinika Okulistyki, Akademia Medyczna we Wrocławiu
City
Wrocław
Country
Poland
Facility Name
Republican Ophthalmologic Hospital of MH of Republic of Tatarstan
City
Kazan
Country
Russian Federation
Facility Name
IRTC "Eye Microsurgery" n. a. S.N. Fyodorov
City
Moscow
Country
Russian Federation
Facility Name
Moscow Scientific Research Institute of Eye Diseases
City
Moscow
Country
Russian Federation
Facility Name
CJSC "Inter Yuna"
City
Rostov-on Don
Country
Russian Federation
Facility Name
City Consultative Diagnostic Centre # 1 (St. Petersburg)
City
St. Petersburg
Country
Russian Federation
Facility Name
IRTC "Eye Microsurgery" n. a. S.N. Fyodorov
City
St. Petersburg
Country
Russian Federation
Facility Name
Military Medical Academy n.a. S.M.Kirov of Ministry of Defence
City
St. Petersburg
Country
Russian Federation
Facility Name
St. Petersburg State Medical University n. a. Pavlov
City
St. Petersburg
Country
Russian Federation
Facility Name
Kyiv City Centre of Eye Vascular and Endocrine Diseases of Organ of Vision
City
Kyiv
Country
Ukraine
Facility Name
Kyiv City Ophthalmologic Hospital "Eye Microsurgery Centre"
City
Kyiv
Country
Ukraine
Facility Name
Kyiv City Ophthalmologic Hospital
City
Kyiv
Country
Ukraine
Facility Name
V.P. Filatov Institute of Eye Diseases and Tissue Pathology of AMS of Ukraine
City
Odessa
Country
Ukraine
Facility Name
Zaporizhzhya Center of Vision Rehabilitation
City
Odessa
Country
Ukraine
Facility Name
S.I. Georgiyevsky Crimean State Medical University
City
Simferopol
Country
Ukraine

12. IPD Sharing Statement

Links:
URL
http://www.comentis.com
Description
Related Info

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

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