Safety and Efficacy of ATG003 in Patients With AMD Receiv... | NCT00607750

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

NCT00607750

Sponsor

CoMentis

Status

Completed

Last Update Posted

Oct 28, 2010Estimated

Enrollment

60Actual

Phase

Phase 2

Conditions

Age-Related Macular Degeneration

Interventions

ATG003 (mecamylamine)
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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)

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Apr 2010Actual

Completion Date

May 2010Actual

First Submitted Date

Jan 23, 2008

First Submission Date that Met QC Criteria

Jan 23, 2008

First Posted Date

Feb 6, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2010

Last Update Posted Date

Oct 28, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Placebo Comparator		Drug: Placebo
ATG003	Experimental		Drug: ATG003 (mecamylamine)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ATG003 (mecamylamine)	Drug	1% Ophthalmic solution, eyedrop BID, 48 weeks	ATG003

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

> 55 years of age
clinical diagnosis of neovascular AMD

Exclusion Criteria:

confounding ocular condition

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

56 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Carl Grove, MS	Comentis, Inc.	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D008268	Macular Degeneration

Ancestor Terms

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008464	Mecamylamine

Ancestor Terms

ID	Term
D009636	Norbornanes
D001643	Bridged Bicyclo Compounds
D001952	Bridged-Ring Compounds
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided