Safety and Efficacy of ATG003 in Patients With Wet Age-Related Macular Degeneration (AMD)
- Registration Number
- NCT00414206
- Lead Sponsor
- CoMentis
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Not specified
- Target Recruitment
- 343
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 0.3% mecamylamine Mecamylamine - Placebo Placebo - 1% mecamylamine Mecamylamine -
- Primary Outcome Measures
Name Time Method Proportion of Subjects Losing Fewer Than 15 ETDRS Letters of Visual Acuity at 48 Weeks Compared to Baseline. Baseline to Week 48
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (41)
Hospital San José Tec de Monterrey
🇲🇽Monterrey, Mexico
Oddział Okulistyczny Okręgowy Szpital Kolejowy
🇵🇱Katowice, Poland
Oddział Okulistyki, Samodzielny Publiczny Szpital Kliniczny Nr 1 Przemienienia Pańskiego AM w Poznaniu
🇵🇱Poznań, Poland
University Hospital Olomouc, Department of Ophthalmology
🇨🇿Olomouc, Czech Republic
Instituto da Visão
🇧🇷Belo Horizonte, Brazil
Centro Brasileiro de Ciências Visuais
🇧🇷Belo Horizonte, Brazil
Hospital de Clinicas de Porto Alegre
🇧🇷Porto Alegre, Brazil
Clínica de Olhos Dr. Suel Abujamra
🇧🇷São Paulo, Brazil
Hospital Universitário Clementino Fraga Filho
🇧🇷Rio de Janeiro, Brazil
Hospital São Paulo - Setor de Pesquisa Clínica
🇧🇷São Paulo, Brazil
Eye Clinic University Hospital
🇨🇿Hradec Kralove, Czech Republic
Ophthalmology Nemocnice Litomysl
🇨🇿Litomyšl, Czech Republic
Hospital Conde de Valenciana
🇲🇽CP, Mexico
Klinika Chorób Oczu
🇵🇱Gdansk, Poland
Kyiv City Ophthalmologic Hospital
🇺🇦Kyiv, Ukraine
Hospital de Olhos de Araraquara
🇧🇷Araraquara, Brazil
Centro Brasileiro de Cirurgia dos Olhos
🇧🇷Goiânia, Brazil
Hospital de Olhos de São Paulo
🇧🇷São Paulo, Brazil
Hospital das Clínicas Faculdade de Medicina da Universidade de São Paulo
🇧🇷São Paulo, Brazil
Cornea Lexum Praha
🇨🇿Praha, Czech Republic
Asociación Para Evitar la Ceguera
🇲🇽Mexico City, Mexico
Hospital General de México
🇲🇽Mexico City, Mexico
Klinika Okulistyczna
🇵🇱Lodz, Poland
Katedra i Klinika Okulistyki, Samodzielny Publiczny Kliniczny Szpital Okulistyczny
🇵🇱Warsaw, Poland
Katedra i Klinika Okulistyki, Akademia Medyczna we Wrocławiu
🇵🇱Wrocław, Poland
IRTC "Eye Microsurgery" n. a. S.N. Fyodorov
🇷🇺St. Petersburg, Russian Federation
CJSC "Inter Yuna"
🇷🇺Rostov-on Don, Russian Federation
Republican Ophthalmologic Hospital of MH of Republic of Tatarstan
🇷🇺Kazan, Russian Federation
Military Medical Academy n.a. S.M.Kirov of Ministry of Defence
🇷🇺St. Petersburg, Russian Federation
Moscow Scientific Research Institute of Eye Diseases
🇷🇺Moscow, Russian Federation
Kyiv City Centre of Eye Vascular and Endocrine Diseases of Organ of Vision
🇺🇦Kyiv, Ukraine
Kyiv City Ophthalmologic Hospital "Eye Microsurgery Centre"
🇺🇦Kyiv, Ukraine
Zaporizhzhya Center of Vision Rehabilitation
🇺🇦Odessa, Ukraine
S.I. Georgiyevsky Crimean State Medical University
🇺🇦Simferopol, Ukraine
Fundación Hospital "Nuestra Sra de la Luz" I.A.P.
🇲🇽Delegación Cuauhtémoc, Mexico
University Hospital Brno, Department of Ophthalmology
🇨🇿Brno, Czech Republic
Faculty Hospital Kralovske Vinohrady, Dept. of Ophthalmology
🇨🇿Prague, Czech Republic
Cif Biotec
🇲🇽CP, Mexico
City Consultative Diagnostic Centre # 1 (St. Petersburg)
🇷🇺St. Petersburg, Russian Federation
St. Petersburg State Medical University n. a. Pavlov
🇷🇺St. Petersburg, Russian Federation
V.P. Filatov Institute of Eye Diseases and Tissue Pathology of AMS of Ukraine
🇺🇦Odessa, Ukraine