Macular DegenerationPhase 2NCT00414206
Safety and Efficacy of ATG003 in Patients With Wet Age-Related Macular Degeneration (AMD)
A Phase 2 study testing Mecamylamine in people with Macular Degeneration, run by CoMentis at 42 sites in 6 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- Mecamylamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 343 participants
- Where
- 42 sitesin 6 countries
- Study dates
- Mar 2007to Sep 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Trial locations and contacts
42 sites in 6 countries.
42 sites in 6 countries
Brazil10 sites
Hospital de Olhos de Araraquara
Araraquara
Centro Brasileiro de Ciências Visuais
Belo Horizonte
Instituto da Visão
Belo Horizonte
Centro Brasileiro de Cirurgia dos Olhos
Goiânia
Hospital de Clinicas de Porto Alegre
Porto Alegre
Hospital Universitário Clementino Fraga Filho
Rio de Janeiro
Clínica de Olhos Dr. Suel Abujamra
São Paulo
Hospital das Clínicas Faculdade de Medicina da Universidade de São Paulo
São Paulo
Hospital de Olhos de São Paulo
São Paulo
Hospital São Paulo - Setor de Pesquisa Clínica
São Paulo
Russia8 sites
Republican Ophthalmologic Hospital of MH of Republic of Tatarstan
Kazan'
IRTC "Eye Microsurgery" n. a. S.N. Fyodorov
Moscow
Moscow Scientific Research Institute of Eye Diseases
Moscow
CJSC "Inter Yuna"
Rostov-on-Don
City Consultative Diagnostic Centre # 1 (St. Petersburg)
Saint Petersburg
IRTC "Eye Microsurgery" n. a. S.N. Fyodorov
Saint Petersburg
Military Medical Academy n.a. S.M.Kirov of Ministry of Defence
Saint Petersburg
St. Petersburg State Medical University n. a. Pavlov
Saint Petersburg
Czechia6 sites
University Hospital Brno, Department of Ophthalmology
Brno
Eye Clinic University Hospital
Hradec Králové
Ophthalmology Nemocnice Litomysl
Litomyšl
University Hospital Olomouc, Department of Ophthalmology
Olomouc
Cornea Lexum Praha
Prague
Faculty Hospital Kralovske Vinohrady, Dept. of Ophthalmology
Prague
Mexico6 sites
Cif Biotec
CP
Hospital Conde de Valenciana
CP
Fundación Hospital "Nuestra Sra de la Luz" I.A.P.
Delegación Cuauhtémoc
Asociación Para Evitar la Ceguera
Mexico City
Hospital General de México
Mexico City
Hospital San José Tec de Monterrey
Monterrey
Poland6 sites
Klinika Chorób Oczu
Gdansk
Oddział Okulistyczny Okręgowy Szpital Kolejowy
Katowice
Klinika Okulistyczna
Lodz
Oddział Okulistyki, Samodzielny Publiczny Szpital Kliniczny Nr 1 Przemienienia Pańskiego AM w Poznaniu
Poznan
Katedra i Klinika Okulistyki, Samodzielny Publiczny Kliniczny Szpital Okulistyczny
Warsaw
Katedra i Klinika Okulistyki, Akademia Medyczna we Wrocławiu
Wroclaw
Ukraine6 sites
Kyiv City Centre of Eye Vascular and Endocrine Diseases of Organ of Vision
Kyiv
Kyiv City Ophthalmologic Hospital "Eye Microsurgery Centre"
Kyiv
Kyiv City Ophthalmologic Hospital
Kyiv
V.P. Filatov Institute of Eye Diseases and Tissue Pathology of AMS of Ukraine
Odesa
Zaporizhzhya Center of Vision Rehabilitation
Odesa
S.I. Georgiyevsky Crimean State Medical University
Simferopol
About this study
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).
- Conditions
- Macular Degeneration
- Being tested
- Mecamylamine, Placebo
- Keywords
- AMD, Wet AMD
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MecamylamineDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1% mecamylamine | Active comparator | Not described Receives: Drug: Mecamylamine |
| 0.3% mecamylamine | Active comparator | Not described Receives: Drug: Mecamylamine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects Losing Fewer Than 15 ETDRS Letters of Visual Acuity at 48 Weeks Compared to Baseline.
Measured: Baseline to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2006 (estimated)
- Study startMar 2007
- Primary completionJun 2009
- Study completionSep 2009
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 343 participants (actual)
Sponsor and investigators
- Lead sponsor
- CoMentis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Carl Grove, Study director, CoMentis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00414206
- Sponsor's protocol ID
- ATG003-201
- Status last verified
- Oct 2010
- First submitted
- 19 Dec 2006
- Last updated
- 23 Nov 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00414206
- Acronym / sponsor ID
- ATG003-201
- Conditions
- Macular Degeneration
- Keywords
- AMD, Wet AMD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 343 participants (actual)
- Lead sponsor
- CoMentisIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 21 Dec 2006 (estimated)
- Results
- Posted 23 Nov 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1% mecamylamine | Active comparator | Drug: Mecamylamine |
| 0.3% mecamylamine | Active comparator | Drug: Mecamylamine |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mecamylamine | Drug | 0.3% mecamylamine, 1% mecamylamine |
| Placebo | Drug | Placebo |
Primary outcome
Proportion of Subjects Losing Fewer Than 15 ETDRS Letters of Visual Acuity at 48 Weeks Compared to Baseline.
Time frame: Baseline to Week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl Grove study director
CoMentis
42 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mecamylamine in people with Macular Degeneration, run by CoMentis at 42 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in Brazil, Russia, Czechia, Mexico, Poland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Subjects Losing Fewer Than 15 ETDRS Letters of Visual Acuity at 48 Weeks Compared to Baseline. (time frame: Baseline to Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2010.