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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00139282
Other study ID # MSI-1256F-301
Secondary ID
Status Terminated
Phase Phase 3
First received August 29, 2005
Last updated November 27, 2007
Start date June 2005

Study information

Verified date November 2007
Source Genaera Corporation
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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 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 evaluate the safety and efficacy of Squalamine lactate in the treatment of AMD in patients, the exact number of which will be determined based on data from the sponsor's ongoing Phase 2 trials.

The trial objective is to evaluate the safety and efficacy of two doses of Squalamine lactate for Injection administered as intravenous infusions weekly for 4 weeks followed by maintenance doses every 4 weeks through week 104 compared with the safety and efficacy in the control group.


Recruitment information / eligibility

Status Terminated
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Prior treatment for "wet" age-related macular degeneration in the affected eye in the past 3 months

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Squalamine Lactate


Locations

Country Name City State
United States Retina Research Center Austin Texas
United States Retina-Vitreous Associates Medical Group Beverly Hills California
United States Florida Eye Microsurgical Institute Boynton Beach Florida
United States Charlotte Eye, Ear, Nose & Throat Associates Charlotte North Carolina
United States Horizon Eye Care Charlotte North Carolina
United States Carolina Retina Center Columbia South Carolina
United States The Ohio State University, Havener Eye Institute Columbus Ohio
United States National Ophthalmic Research Institute Fort Myers Florida
United States Cumberland Valley Retina Consultants, PC Hagerstown Maryland
United States Penn State Ophthalmology Hershey Pennsylvania
United States Garcia & Associates, MD, PA Houston Texas
United States Midwest Eye Institute Indianapolis Indiana
United States University of Florida Jacksonville Florida
United States Southeastern Retina Associates Kingsport Tennessee
United States Delaware Valley Retina Associates Lawrenceville New Jersey
United States Virginia Retina Center Leesburg Virginia
United States Eldorado Retina Associates Louisville Colorado
United States MaculaCare New York New York
United States Magruder Eye Institute Orlando Florida
United States Retina Vitreous Consultants Pittsburgh Pennsylvania
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States Genaera Corporation Plymouth Meeting Pennsylvania
United States Black Hills Regional Eye Institute Rapid City South Dakota
United States John Moran Eye Center Salt Lake City Utah
United States Retina Associates, PA Shawnee Mission Kansas
United States East Florida Eye Institute Stuart Florida
United States Retina Associates of Florida Tampa Florida
United States Retina Associates of New Jersey Teaneck New Jersey
United States Center for Retina and Macular Disease Winter Haven Florida

Sponsors (1)

Lead Sponsor Collaborator
Genaera Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Loss in best corrected visual acuity (BCVA) of greater than or equal to 15 letters (ETDRS) at 52 weeks in the study eye compared to baseline.
Secondary Change in retinal thickness in the study eye at 52 and 104 weeks compared to baseline, as measured by OCT, in a subset of subjects
Secondary Change in area of CNV in the study eye at 52 and 104 weeks compared to baseline, as measured by fluorescein angiography
Secondary Gain or loss in BCVA of greater than or equal to 15 letters (ETDRS) at 52 and 104 weeks in the fellow eye compared to baseline in the subgroup of subjects whose fellow eye is affected with wet AMD
Secondary Loss in binocular visual acuity of greater than or equal to 15 letters at 52 and 104 weeks compared to baseline, using a modified ETDRS protocol.
See also
  Status Clinical Trial Phase
Completed NCT00138632 - Safety and Efficacy of Oral PTK787 in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration (AMD) Phase 1/Phase 2
Terminated NCT04594681 - A Safety Study of KHK4951 in Healthy Volunteers and Patients With Wet Age-Related Macular Degeneration Phase 1
Completed NCT03585556 - AAVCAGsCD59 for the Treatment of Wet AMD Phase 1
Completed NCT03362190 - ZIMURA in Combination With LUCENTIS in Patients With Neovascular Age Related Macular Degeneration (NVAMD) Phase 2
Not yet recruiting NCT04564937 - The Study of Drug SCT510A in Patients With Wet Age-related Macular Degeneration (wAMD) Phase 1/Phase 2
Recruiting NCT04504123 - MMP-9 Inhibition for Recalcitrant Wet AMD Phase 2
Terminated NCT02005133 - A Prospective, Observational, Multicentre, 2 Year Study Evaluating the Use of Eylea (Aflibercept) for the Treatment of Neovascular (Wet) Age-related Macular Degeneration in UK NHS Opthalmology Clinics N/A
Completed NCT01016873 - INTREPID - IRay Plus Anti-VEGF Treatment For Patients With Wet AMD Phase 2
Completed NCT03748784 - ADVM-022 Intravitreal Gene Therapy for Wet AMD Phase 1
Recruiting NCT04468997 - The Study of Drug 601 in Patients With Wet Age-related Macular Degeneration (wAMD) Phase 1
Completed NCT04685369 - Effectiveness of Anti-VEGF Treatments in Wet AMD in Active Smokers
Enrolling by invitation NCT04932980 - Comparison of Rapid Aflibercept and Brolucizumab T&E in wAMD N/A
Recruiting NCT05297292 - A Study to Evaluate the Efficacy and Safety of MW02 in the Treatment of nAMD Phase 2/Phase 3
Completed NCT03939767 - Assessment of Proactive Treatments in Patients With Wet Age-related Macular Degeneration (wAMD) Which Have Never Undergone Treatment of This Particular Disease
Completed NCT03066258 - Safety and Tolerability of RGX-314 (Investigational Product) Gene Therapy for Neovascular AMD Trial Phase 1/Phase 2
Terminated NCT01086761 - Study of MP0112 Intravitreal Injection in Patients With Wet Age Related Macular Degeneration Phase 1
Recruiting NCT05727397 - Efficacy and Safety of RC28-E Versus Aflibercept Phase 3
Completed NCT04884399 - Phase I Study to Compare CMAB818 Injection and Lucentis® in Patients With Wet AMD Phase 1
Completed NCT04964089 - A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) Phase 3
Withdrawn NCT01339949 - Study to Evaluate the Safety and Effectiveness of IRay in Wet Age-related Macular Degeneration (AMD) Patients With Recurrent Leakage Secondary to Choroidal Neovascularisation (CNV) N/A

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