NCT00333476

Brief Summary

Age-Related Macular Degeneration (AMD) is a degenerative eye 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 in the treatment of AMD.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
140

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

9 active sites

Status
terminated

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

Study Start

First participant enrolled

May 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 1, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2006

Completed
Last Updated

November 28, 2007

Status Verified

November 1, 2007

First QC Date

June 1, 2006

Last Update Submit

November 27, 2007

Conditions

Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • To evaluate the safety profile of squalamine lactate at doses ranging from 40 mg to 160 mg of squalamine lactate

Secondary Outcomes (2)

  • To evaluate short-term effects on best corrected visual acuity and changes in subretinal CNV as measured by optical coherence tomography

  • To evaluate short-term effects on best corrected visual acuity and changes in subretinal CNV as measured by fluorescein angiography

Interventions

MSI-1256F (Squalamine Lactate)DRUG

Eligibility Criteria

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

You may qualify if:

  • Adult subjects ≥ 50 years of age.
  • minimally classic or active occult choroidal neovascularization associated with age-related macular degeneration in one or both eyes.
  • baseline best corrected visual acuity score between 35 to 65 letters according to the Early Treatment of Diabetic Retinopathy Study protocol.
  • central retinal thickness by optical coherence tomography of \> 250 microns.
  • lesions \> 9 disc areas.
  • \> 25% fibrosis in the lesion.

You may not qualify if:

  • Previous history of triamcinolone, bevacizumab, ranibizumab, or pegaptanib sodium injection therapy in the study eye.
  • retinal or optic nerve disease.
  • uncontrolled diabetes.
  • ongoing malignancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Florida Eye Microsurgical Institute

Boynton Beach, Florida, 33426, United States

Location

Retina Health Center

Fort Meyers, Florida, 33907, United States

Location

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

Midwest Eye Institute

Indianapolis, Indiana, 46280, United States

Location

Retina Specialists

Towson, Maryland, 21204, United States

Location

Eye Foundation of Kansas City

Kansas City, Missouri, 64108, United States

Location

Ophthalmic Consultants of Long Island

Long Island City, New York, 11563, United States

Location

Retina Associates of Western New York

Rochester, New York, 14618, United States

Location

Charles Garcia, MD, P.A.

Houston, Texas, 77002, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

squalamine lactate

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Randy Katz, MD

    Florida Eye Microsurgical Institute, Inc.

    PRINCIPAL INVESTIGATOR

  • Alexander Eaton, MD

    Retina Health Center

    PRINCIPAL INVESTIGATOR

  • Thomas Ciulla, MD

    Midwest Eye Institute

    PRINCIPAL INVESTIGATOR

  • Raymond Sjaarda, MD

    Retina Specialists

    PRINCIPAL INVESTIGATOR

  • Nelson Sabates, MD

    Eye Foundation of Kansas City

    PRINCIPAL INVESTIGATOR

  • Charles Garcia, MD

    Charles Garcia, MD, P.A.

    PRINCIPAL INVESTIGATOR

  • Glenn Stoller, MD

    Ophthalmic Consultants of Long Island

    PRINCIPAL INVESTIGATOR

  • Phillip Rosenfeld, MD

    Bascom Palmer Eye Institute

    PRINCIPAL INVESTIGATOR

  • Steven Rose, MD

    Retina Associates of Western New York

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 1, 2006

First Posted

June 5, 2006

Study Start

May 1, 2006

Last Updated

November 28, 2007

Record last verified: 2007-11

Locations

US(9)