A Study of MSI-1256F (Squalamine Lactate) To Treat Wet Age-Related Macular Degeneration

A Phase 2, Randomized, Open Label, Safety, and Pharmacodynamic Study of Squalamine Lactate for Injection for the Treatment of Minimally Classic or Active Occult Choroidal Neovascularization Associated With Age-Related Macular Degeneration

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00333476

Enrollment

140

Registered

2006-06-05

Start date

2006-05-31

Completion date

Unknown

Last updated

2007-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Degeneration

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.

Interventions

DRUGMSI-1256F (Squalamine Lactate)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
To evaluate the safety profile of squalamine lactate at doses ranging from 40 mg to 160 mg of squalamine lactate	—

Secondary

Measure	Time frame
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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026