NCT00607750

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2008

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 6, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

October 28, 2010

Status Verified

October 1, 2010

Enrollment Period

1.9 years

First QC Date

January 23, 2008

Last Update Submit

October 26, 2010

Conditions

Age-Related Macular Degeneration

Keywords

Wet AMD, Comentis, ATG003, mecamylamine

Outcome Measures

Primary Outcomes (1)

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

    Day 1 - Week 50

Secondary Outcomes (1)

  • To evaluate the efficacy of ATG003

    Day 1 - Week 50

Study Arms (2)

1

PLACEBO COMPARATOR
Drug: Placebo

ATG003

EXPERIMENTAL
Drug: ATG003 (mecamylamine)

Interventions

ATG003 (mecamylamine)DRUG

1% Ophthalmic solution, eyedrop BID, 48 weeks

ATG003
PlaceboDRUG

Placebo eyedrops, BID, 48 weeks

1

Eligibility Criteria

Age56 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • confounding ocular condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Macular Degeneration

Interventions

Mecamylamine

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

NorbornanesBridged Bicyclo CompoundsBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Carl Grove, MS

    Comentis, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 23, 2008

First Posted

February 6, 2008

Study Start

May 1, 2008

Primary Completion

April 1, 2010

Study Completion

May 1, 2010

Last Updated

October 28, 2010

Record last verified: 2010-10