Macular Degeneration Clinical Trial
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)
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).
| Status | Terminated |
| Enrollment | 343 |
| Est. completion date | September 2009 |
| Est. primary completion date | June 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 50 Years and older |
| Eligibility |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Brazil | 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 | |
| Czech Republic | University Hospital Brno, Department of Ophthalmology | Brno | |
| Czech Republic | Eye Clinic University Hospital | Hradec Kralove | |
| Czech Republic | Ophthalmology Nemocnice Litomysl | Litomyšl | |
| Czech Republic | University Hospital Olomouc, Department of Ophthalmology | Olomouc | |
| Czech Republic | Faculty Hospital Kralovske Vinohrady, Dept. of Ophthalmology | Prague | |
| Czech Republic | Cornea Lexum Praha | Praha | |
| Mexico | 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 | |
| Poland | Klinika Chorób Oczu | Gdansk | |
| Poland | Oddzial Okulistyczny Okregowy Szpital Kolejowy | Katowice | |
| Poland | Klinika Okulistyczna | Lodz | |
| Poland | Oddzial Okulistyki, Samodzielny Publiczny Szpital Kliniczny Nr 1 Przemienienia Panskiego AM w Poznaniu | Poznan | |
| Poland | Katedra i Klinika Okulistyki, Samodzielny Publiczny Kliniczny Szpital Okulistyczny | Warsaw | |
| Poland | Katedra i Klinika Okulistyki, Akademia Medyczna we Wroclawiu | Wroclaw | |
| Russian Federation | Republican Ophthalmologic Hospital of MH of Republic of Tatarstan | Kazan | |
| Russian Federation | IRTC "Eye Microsurgery" n. a. S.N. Fyodorov | Moscow | |
| Russian Federation | Moscow Scientific Research Institute of Eye Diseases | Moscow | |
| Russian Federation | CJSC "Inter Yuna" | Rostov-on Don | |
| 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 | St. Petersburg | |
| Ukraine | Kyiv City Centre of Eye Vascular and Endocrine Diseases of Organ of Vision | Kyiv | |
| Ukraine | Kyiv City Ophthalmologic Hospital | Kyiv | |
| Ukraine | Kyiv City Ophthalmologic Hospital "Eye Microsurgery Centre" | Kyiv | |
| Ukraine | V.P. Filatov Institute of Eye Diseases and Tissue Pathology of AMS of Ukraine | Odessa | |
| Ukraine | Zaporizhzhya Center of Vision Rehabilitation | Odessa | |
| Ukraine | S.I. Georgiyevsky Crimean State Medical University | Simferopol |
| Lead Sponsor | Collaborator |
|---|---|
| CoMentis |
Brazil, Czech Republic, Mexico, Poland, Russian Federation, Ukraine,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of Subjects Losing Fewer Than 15 ETDRS Letters of Visual Acuity at 48 Weeks Compared to Baseline. | Baseline to Week 48 | No |
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