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Safety and Efficacy of ATG003 in Patients With AMD Receiving Anti-VEGF

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)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00607750
Enrollment
60
Registered
2008-02-06
Start date
2008-05-31
Completion date
2010-05-31
Last updated
2010-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-Related Macular Degeneration

Keywords

Wet AMD, Comentis, ATG003, mecamylamine

Brief 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.

Interventions

DRUGATG003 (mecamylamine)

1% Ophthalmic solution, eyedrop BID, 48 weeks

DRUGPlacebo

Placebo eyedrops, BID, 48 weeks

Sponsors

CoMentis
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
56 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* \> 55 years of age * clinical diagnosis of neovascular AMD

Exclusion criteria

* confounding ocular condition

Design outcomes

Primary

MeasureTime frame
To evaluate the safety of ATG003 (mecamylamine HCL ophthalmic solution)Day 1 - Week 50

Secondary

MeasureTime frame
To evaluate the efficacy of ATG003Day 1 - Week 50

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026