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

Age-Related Macular Degeneration Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00607750
• Other study ID #: ATG003-203
• Status: Completed
• Phase: Phase 2
• First received: January 23, 2008
• Last updated: October 26, 2010
• Start date: May 2008
• Est. completion date: May 2010

Study information

• Verified date: October 2010
• Source: CoMentis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 56 Years and older

Eligibility

Inclusion Criteria:

• > 55 years of age

• clinical diagnosis of neovascular AMD

Exclusion Criteria:

• confounding ocular condition

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• ATG003 (mecamylamine)
1% Ophthalmic solution, eyedrop BID, 48 weeks
• Placebo
Placebo eyedrops, BID, 48 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CoMentis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety of ATG003 (mecamylamine HCL ophthalmic solution)		Day 1 - Week 50	No
Secondary	To evaluate the efficacy of ATG003		Day 1 - Week 50	No