Clinical trial NCT00414206: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Macular Degeneration
Keywords: AMD
Wet AMD
Lead sponsor: CoMentis
Sponsor class: INDUSTRY
First posted: 2006-12-21
Enrollment: 343
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).



Primary outcomes:
measure: Proportion of Subjects Losing Fewer Than 15 ETDRS Letters of Visual Acuity at 48 Weeks Compared to Baseline.
timeFrame: Baseline to Week 48
Secondary outcomes:
Other outcomes:
Locations:
city: Araraquara
country: Brazil
facility: Hospital de Olhos de Araraquara
city: Belo Horizonte
country: Brazil
facility: Centro Brasileiro de Ciências Visuais
city: Belo Horizonte
country: Brazil
facility: Instituto da Visão
city: Goiânia
country: Brazil
facility: Centro Brasileiro de Cirurgia dos Olhos
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitário Clementino Fraga Filho
city: São Paulo
country: Brazil
facility: Clínica de Olhos Dr. Suel Abujamra
city: São Paulo
country: Brazil
facility: Hospital das Clínicas Faculdade de Medicina da Universidade de São Paulo
city: São Paulo
country: Brazil
facility: Hospital de Olhos de São Paulo
city: São Paulo
country: Brazil
facility: Hospital São Paulo - Setor de Pesquisa Clínica
city: Brno
country: Czech Republic
facility: University Hospital Brno, Department of Ophthalmology
city: Hradec Kralove
country: Czech Republic
facility: Eye Clinic University Hospital
city: Litomyšl
country: Czech Republic
facility: Ophthalmology Nemocnice Litomysl
city: Olomouc
country: Czech Republic
facility: University Hospital Olomouc, Department of Ophthalmology
city: Prague
country: Czech Republic
facility: Faculty Hospital Kralovske Vinohrady, Dept. of Ophthalmology
city: Praha
country: Czech Republic
facility: Cornea Lexum Praha
city: CP
country: Mexico
facility: Cif Biotec
city: CP
country: Mexico
facility: Hospital Conde de Valenciana
city: Delegación Cuauhtémoc
country: Mexico
facility: Fundación Hospital "Nuestra Sra de la Luz" I.A.P.
city: Mexico City
country: Mexico
facility: Asociación Para Evitar la Ceguera
city: Mexico City
country: Mexico
facility: Hospital General de México
city: Monterrey
country: Mexico
facility: Hospital San José Tec de Monterrey
city: Gdansk
country: Poland
facility: Klinika Chorób Oczu
city: Katowice
country: Poland
facility: Oddział Okulistyczny Okręgowy Szpital Kolejowy
city: Lodz
country: Poland
facility: Klinika Okulistyczna
city: Poznań
country: Poland
facility: Oddział Okulistyki, Samodzielny Publiczny Szpital Kliniczny Nr 1 Przemienienia Pańskiego AM w Poznaniu
city: Warsaw
country: Poland
facility: Katedra i Klinika Okulistyki, Samodzielny Publiczny Kliniczny Szpital Okulistyczny
city: Wrocław
country: Poland
facility: Katedra i Klinika Okulistyki, Akademia Medyczna we Wrocławiu
city: Kazan
country: Russian Federation
facility: Republican Ophthalmologic Hospital of MH of Republic of Tatarstan
city: Moscow
country: Russian Federation
facility: IRTC "Eye Microsurgery" n. a. S.N. Fyodorov
city: Moscow
country: Russian Federation
facility: Moscow Scientific Research Institute of Eye Diseases
city: Rostov-on Don
country: Russian Federation
facility: CJSC "Inter Yuna"
city: St. Petersburg
country: Russian Federation
facility: City Consultative Diagnostic Centre # 1 (St. Petersburg)
city: St. Petersburg
country: Russian Federation
facility: IRTC "Eye Microsurgery" n. a. S.N. Fyodorov
city: St. Petersburg
country: Russian Federation
facility: Military Medical Academy n.a. S.M.Kirov of Ministry of Defence
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State Medical University n. a. Pavlov
city: Kyiv
country: Ukraine
facility: Kyiv City Centre of Eye Vascular and Endocrine Diseases of Organ of Vision
city: Kyiv
country: Ukraine
facility: Kyiv City Ophthalmologic Hospital "Eye Microsurgery Centre"
city: Kyiv
country: Ukraine
facility: Kyiv City Ophthalmologic Hospital
city: Odessa
country: Ukraine
facility: V.P. Filatov Institute of Eye Diseases and Tissue Pathology of AMS of Ukraine
city: Odessa
country: Ukraine
facility: Zaporizhzhya Center of Vision Rehabilitation
city: Simferopol
country: Ukraine
facility: S.I. Georgiyevsky Crimean State Medical University
Study officials:
affiliation: CoMentis
name: Carl Grove
role: STUDY_DIRECTOR
References: