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Safety and Efficacy of ATG003 in Patients With Wet Age-Related Macular Degeneration (AMD)
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)
1 other identifier
interventional
343
6 countries
42
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2007
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2006
CompletedFirst Posted
Study publicly available on registry
December 21, 2006
CompletedStudy Start
First participant enrolled
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedResults Posted
Study results publicly available
November 23, 2010
CompletedNovember 23, 2010
October 1, 2010
2.3 years
December 19, 2006
August 16, 2010
October 26, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Subjects Losing Fewer Than 15 ETDRS Letters of Visual Acuity at 48 Weeks Compared to Baseline.
Baseline to Week 48
Study Arms (3)
1% mecamylamine
ACTIVE COMPARATOR0.3% mecamylamine
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Sponsors & Collaborators
- CoMentislead
Study Sites (42)
Hospital de Olhos de Araraquara
Araraquara, Brazil
Centro Brasileiro de Ciências Visuais
Belo Horizonte, Brazil
Instituto da Visão
Belo Horizonte, Brazil
Centro Brasileiro de Cirurgia dos Olhos
Goiânia, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Brazil
Hospital Universitário Clementino Fraga Filho
Rio de Janeiro, Brazil
Clínica de Olhos Dr. Suel Abujamra
São Paulo, Brazil
Hospital das Clínicas 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
São Paulo, Brazil
University Hospital Brno, Department of Ophthalmology
Brno, Czechia
Eye Clinic University Hospital
Hradec Králové, Czechia
Ophthalmology Nemocnice Litomysl
Litomyšl, Czechia
University Hospital Olomouc, Department of Ophthalmology
Olomouc, Czechia
Cornea Lexum Praha
Prague, Czechia
Faculty Hospital Kralovske Vinohrady, Dept. of Ophthalmology
Prague, Czechia
Cif Biotec
CP, Mexico
Hospital Conde de Valenciana
CP, Mexico
Fundación Hospital "Nuestra Sra de la Luz" I.A.P.
Delegación Cuauhtémoc, Mexico
Asociación Para Evitar la Ceguera
Mexico City, Mexico
Hospital General de México
Mexico City, Mexico
Hospital San José Tec de Monterrey
Monterrey, Mexico
Klinika Chorób Oczu
Gdansk, Poland
Oddział Okulistyczny Okręgowy Szpital Kolejowy
Katowice, Poland
Klinika Okulistyczna
Lodz, Poland
Oddział Okulistyki, Samodzielny Publiczny Szpital Kliniczny Nr 1 Przemienienia Pańskiego AM w Poznaniu
Poznan, Poland
Katedra i Klinika Okulistyki, Samodzielny Publiczny Kliniczny Szpital Okulistyczny
Warsaw, Poland
Katedra i Klinika Okulistyki, Akademia Medyczna we Wrocławiu
Wroclaw, Poland
Republican Ophthalmologic Hospital of MH of Republic of Tatarstan
Kazan', Russia
IRTC "Eye Microsurgery" n. a. S.N. Fyodorov
Moscow, Russia
Moscow Scientific Research Institute of Eye Diseases
Moscow, Russia
CJSC "Inter Yuna"
Rostov-on-Don, Russia
City Consultative Diagnostic Centre # 1 (St. Petersburg)
Saint Petersburg, Russia
IRTC "Eye Microsurgery" n. a. S.N. Fyodorov
Saint Petersburg, Russia
Military Medical Academy n.a. S.M.Kirov of Ministry of Defence
Saint Petersburg, Russia
St. Petersburg State Medical University n. a. Pavlov
Saint Petersburg, Russia
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
Kyiv, Ukraine
V.P. Filatov Institute of Eye Diseases and Tissue Pathology of AMS of Ukraine
Odesa, Ukraine
Zaporizhzhya Center of Vision Rehabilitation
Odesa, Ukraine
S.I. Georgiyevsky Crimean State Medical University
Simferopol, Ukraine
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Carl Grove
- Organization
- CoMentis, Inc.
Study Officials
- STUDY DIRECTOR
Carl Grove
CoMentis
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 19, 2006
First Posted
December 21, 2006
Study Start
March 1, 2007
Primary Completion
June 1, 2009
Study Completion
September 1, 2009
Last Updated
November 23, 2010
Results First Posted
November 23, 2010
Record last verified: 2010-10