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OpenTrials
Completed

NCT Number: NCT00607750

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

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.

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Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

56 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • > 55 years of age
  • clinical diagnosis of neovascular AMD

Exclusion criteria

  • confounding ocular condition

Treatment and study plan

ATG003 (mecamylamine)

Drug

1% Ophthalmic solution, eyedrop BID, 48 weeks

Placebo

Drug

Placebo eyedrops, BID, 48 weeks

Primary outcomes

  1. To evaluate the safety of ATG003 (mecamylamine HCL ophthalmic solution)

    Time frame: Day 1 - Week 50

Secondary outcomes

  1. To evaluate the efficacy of ATG003

    Time frame: Day 1 - Week 50

Sponsors and collaborators

Lead sponsor

CoMentis

Industry

Registry information

Official study 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)

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Feb 6, 2008
Registry last updated
Oct 28, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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