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

NCT00414206 — Phase 2, Terminated, 343 participants, CoMentis

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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)

Registry	NCT00414206
Status	Terminated - Sponsor decision
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	343 (Actual)
Sponsor	CoMentis (Industry)
Conditions	Macular Degeneration
Interventions	Mecamylamine, Placebo (Drug)
Dates	start 2007-03-01, primary completion 2009-06-01, completion 2009-09-01, first posted 2006-12-21, last updated 2010-11-23
Locations	42 sites in Brazil, Czechia, Mexico, Poland, Russia, Ukraine

-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).

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+Arms and interventions

Arm	Type	Interventions
1% mecamylamine	Active comparator	Drug: Mecamylamine
0.3% mecamylamine	Active comparator	Drug: Mecamylamine
Placebo	Placebo comparator	Drug: Placebo

Mecamylamine (Drug)
Placebo (Drug)

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 50 Years to any

+Posted results

Participant flow

Milestone	1% Mecamylamine	0.3% Mecamylamine	Placebo
Started	115	114	114
Completed	57	58	59
Not completed	58	56	55

Outcome results

Proportion of Subjects Losing Fewer Than 15 ETDRS Letters of Visual Acuity at 48 Weeks Compared to Baseline. (Primary), Number, Percent of subjects: 1% Mecamylamine 88; 0.3% Mecamylamine 86; Placebo 92 (p >0.05)

Adverse events

Arm	Serious adverse events	Other adverse events
1% Mecamylamine	8/115 (7.0%)	68/115 (59.1%)
0.3% Mecamylamine	8/115 (7.0%)	57/114 (50.0%)
Placebo	7/114 (6.1%)	57/114 (50.0%)

Serious adverse events by term

Term	Organ system	1% Mecamylamine	0.3% Mecamylamine	Placebo
Anaemia	Blood and lymphatic system disorders	0/115	1/115	0/114
Atrial fibrillation	Cardiac disorders	1/115	1/115	0/114
Acute myocardial infarction	Cardiac disorders	0/115	0/115	1/114
Atrioventricular block	Cardiac disorders	0/115	1/115	0/114
Cardiac failure	Cardiac disorders	0/115	1/115	0/114
Myocardial ischaemia	Cardiac disorders	0/115	0/115	1/114
Retinal haemorrhage	Eye disorders	1/115	1/115	0/114
Retinal detachment	Eye disorders	1/115	0/115	0/114
Vitreous haemorrhage	Eye disorders	0/115	1/115	0/114
Diarrhoea	Gastrointestinal disorders	0/115	0/115	1/114
Duodenal ucler	General disorders	0/115	0/115	1/114
Reflux gastritis	Gastrointestinal disorders	0/115	1/115	0/114
Cholelithiasis obstructive	Hepatobiliary disorders	0/115	1/115	0/114
Pneumonia	Infections and infestations	0/115	2/115	0/114
Diverticulitis	Infections and infestations	1/115	0/115	0/114
Clavicle fracture	Injury, poisoning and procedural complications	0/115	0/115	1/114
Tibia fracture	Injury, poisoning and procedural complications	1/115	0/115	0/114
Cerebrovascular accident	Nervous system disorders	2/115	0/115	0/114
Cerebral infarction	Nervous system disorders	1/115	0/115	0/114
Calculus bladder	Renal and urinary disorders	0/115	0/115	1/114
Benign prostatic hyperplasia	Reproductive system and breast disorders	0/115	1/115	0/114
Hypertensive crisis	Vascular disorders	0/115	0/115	1/114

Other adverse events by term

Term	Organ system	1% Mecamylamine	0.3% Mecamylamine	Placebo
Cardiac disorders	Cardiac disorders	4/115	8/114	4/114
Visual acuity reduced	Eye disorders	38/115	31/114	38/114
Retinal haemorrhage	Eye disorders	17/115	11/114	16/114
Cataract	Eye disorders	7/115	0/114	1/114
Gastrointestinal disorders	Gastrointestinal disorders	9/115	5/114	8/114
Infections and Infestiations	Infections and infestations	19/115	16/114	12/114
Investigations	Investigations	4/115	6/114	7/114
Musculoskeletal and connective tissue disorders	Musculoskeletal and connective tissue disorders	8/115	5/114	4/114
Nervous system disorders	Nervous system disorders	15/115	2/114	9/114
Headache	Nervous system disorders	6/115	2/114	4/114
Vascular disorders	Vascular disorders	6/115	3/114	6/114

+Locations (42)

Facility	City	Country
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

+Investigators

Carl Grove, Study director, CoMentis