NCT00094120

Brief Summary

Age-Related Macular Degeneration (AMD) is a degenerative disease of the retina that causes a progressive loss of central vision. AMD is the leading cause of legal blindness among adults age 50 or older in the Western world. AMD presents in two different types - "dry" and the more severe "wet" form. Wet AMD is caused by the growth of abnormal blood vessels in the macula. Squalamine lactate is an investigational drug that may prevent the growth of these abnormal blood vessels. This study will test the safety and efficacy of Squalamine when administered with verteporfin therapy in patients with "wet" AMD.

Trial Health

57
Monitor

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 Oct 2004

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 14, 2004

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

January 9, 2008

Status Verified

November 1, 2007

Enrollment Period

2.3 years

First QC Date

October 11, 2004

Last Update Submit

January 8, 2008

Conditions

Macular Degeneration

Keywords

Age-Related Macular Degeneration - Wet Type

Interventions

MSI-1256F (Squalamine Lactate)DRUG

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a diagnosis of "wet" age-related macular degeneration

You may not qualify if:

  • Prior treatment for "wet" age-related macular degeneration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Genaera Corporation

Plymouth Meeting, Pennsylvania, 19462, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

squalamine lactate

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 11, 2004

First Posted

October 14, 2004

Study Start

October 1, 2004

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

January 9, 2008

Record last verified: 2007-11

Locations

US(1)