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

October 26, 2010 updated by: CoMentis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

56 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • confounding ocular condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Drug: Placebo
Placebo eyedrops, BID, 48 weeks
Experimental: ATG003
Drug: ATG003 (mecamylamine)
1% Ophthalmic solution, eyedrop BID, 48 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the safety of ATG003 (mecamylamine HCL ophthalmic solution)
Time Frame: Day 1 - Week 50
Day 1 - Week 50

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the efficacy of ATG003
Time Frame: Day 1 - Week 50
Day 1 - Week 50

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CoMentis

Investigators

  • Study Director: Carl Grove, MS, Comentis, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

January 23, 2008

First Submitted That Met QC Criteria

January 23, 2008

First Posted (Estimate)

February 6, 2008

Study Record Updates

Last Update Posted (Estimate)

October 28, 2010

Last Update Submitted That Met QC Criteria

October 26, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATG003-203

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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