Age-Related Macular DegenerationPhase 2NCT00607750
Safety and Efficacy of ATG003 in Patients With AMD Receiving Anti-VEGF
A Phase 2 study testing ATG003 (mecamylamine) in people with Age-Related Macular Degeneration, run by CoMentis.
Trial summary
This study is a double-masked, randomized, placebo-controlled study of the safety and preliminary efficacy of ATG003 (topical mecamylamine) in patients receiving maintenance injections of either ranibizumab or bevacizumab. Study Hypothesis: Mecamylamine could be effective in the treatment of neovascular AMD. Read more about this study
- Who is it for?
- Ages 56 years and older
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- ATG003 (mecamylamine)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- May 2008to May 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 56 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 55 years of age
- clinical diagnosis of neovascular AMD
Who cannot join
- confounding ocular condition
About this study
Official title: A Phase 2 Randomized, Double-Masked, Study to Evaluate the Safety and Preliminary Efficacy of ATG003 in Patients With Neovascular Age-Related Macular Degeneration (NV-AMD) Receiving Frequent Maintenance Intravitreal Anti-VEGF Antibody Therapy (Ranibizumab or Bevacizumab)
This study is a double-masked, randomized, placebo-controlled study of the safety and preliminary efficacy of ATG003 (topical mecamylamine) in patients receiving maintenance injections of either ranibizumab or bevacizumab. Study Hypothesis: Mecamylamine could be effective in the treatment of neovascular AMD.
- Conditions
- Age-Related Macular Degeneration
- Being tested
- ATG003 (mecamylamine), Placebo
- Keywords
- Wet AMD, Comentis, ATG003, mecamylamine
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATG003 (mecamylamine)Drug
1% Ophthalmic solution, eyedrop BID, 48 weeks
PlaceboDrug
Placebo eyedrops, BID, 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: Placebo |
| ATG003 | Experimental | Not described Receives: Drug: ATG003 (mecamylamine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of ATG003 (mecamylamine HCL ophthalmic solution)
Measured: Day 1 - Week 50
Secondary outcomes (1)
To evaluate the efficacy of ATG003
Measured: Day 1 - Week 50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startMay 2008
- Primary completionApr 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- CoMentis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Carl Grove, MS, Study director, Comentis, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00607750
- Sponsor's protocol ID
- ATG003-203
- Status last verified
- Oct 2010
- First submitted
- 23 Jan 2008
- Last updated
- 28 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Double-Masked, Study to Evaluate the Safety and Preliminary Efficacy of ATG003 in Patients With Neovascular Age-Related Macular Degeneration (NV-AMD) Receiving Frequent Maintenance Intravitreal Anti-VEGF Antibody Therapy (Ranibizumab or Bevacizumab)
- ClinicalTrials.gov ID
- NCT00607750
- Acronym / sponsor ID
- ATG003-203
- Conditions
- Age-Related Macular Degeneration
- Keywords
- Wet AMD, Comentis, ATG003, mecamylamine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- CoMentisIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 6 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a double-masked, randomized, placebo-controlled study of the safety and preliminary efficacy of ATG003 (topical mecamylamine) in patients receiving maintenance injections of either ranibizumab or bevacizumab. Study Hypothesis: Mecamylamine could be effective in the treatment of neovascular AMD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Placebo |
| ATG003 | Experimental | Drug: ATG003 (mecamylamine) |
Who may qualify
- Ages
- 56 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- > 55 years of age
- clinical diagnosis of neovascular AMD
Key exclusion criteria (1 listed)
- confounding ocular condition
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 |
|---|---|---|
| ATG003 (mecamylamine)1% Ophthalmic solution, eyedrop BID, 48 weeks | Drug | ATG003 |
| PlaceboPlacebo eyedrops, BID, 48 weeks | Drug | 1 |
Primary outcome
To evaluate the safety of ATG003 (mecamylamine HCL ophthalmic solution)
Time frame: Day 1 - Week 50
1 secondary outcome
To evaluate the efficacy of ATG003
Time frame: Day 1 - Week 50
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2010.
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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, MS study director
Comentis, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ATG003 (mecamylamine) in people with Age-Related Macular Degeneration, run by CoMentis.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. 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: finished, as of the sponsor's last update on 28 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate the safety of ATG003 (mecamylamine HCL ophthalmic solution) (time frame: Day 1 - Week 50). 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 28 Oct 2010.