"Wet" Age-Related Macular DegenerationPhase 3NCT00139282
A Safety and Efficacy Study of Squalamine Lactate for Injection (MSI-1256F) for "Wet" Age-Related Macular Degeneration
A Phase 3 study testing Squalamine Lactate in people with "Wet" Age-Related Macular Degeneration, run by Genaera Corporation at 29 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- "Wet" Age-Related Macular Degeneration
- What is being tested?
- Squalamine Lactate
- How many people
- Not given
- Where
- 29 sitesUnited States
- Study dates
- Jun 2005to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of "wet" age-related macular degeneration
Who cannot join
- Prior treatment for "wet" age-related macular degeneration in the affected eye in the past 3 months
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Retina Research Center
Austin, Texas, 78705
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211
Florida Eye Microsurgical Institute
Boynton Beach, Florida, 33426
Charlotte Eye, Ear, Nose & Throat Associates
Charlotte, North Carolina, 28210
Horizon Eye Care
Charlotte, North Carolina, 28211
Carolina Retina Center
Columbia, South Carolina, 29223
The Ohio State University, Havener Eye Institute
Columbus, Ohio, 43210
National Ophthalmic Research Institute
Fort Myers, Florida, 33912
Cumberland Valley Retina Consultants, PC
Hagerstown, Maryland, 21740
Penn State Ophthalmology
Hershey, Pennsylvania, 17033
Garcia & Associates, MD, PA
Houston, Texas, 77002
Midwest Eye Institute
Indianapolis, Indiana, 46280
University of Florida
Jacksonville, Florida, 32256
Southeastern Retina Associates
Kingsport, Tennessee, 37660
Delaware Valley Retina Associates
Lawrenceville, New Jersey, 08648
Virginia Retina Center
Leesburg, Virginia, 20176
Eldorado Retina Associates
Louisville, Colorado, 80027
MaculaCare
New York, New York, 10021
Magruder Eye Institute
Orlando, Florida, 32803
Retina Vitreous Consultants
Pittsburgh, Pennsylvania, 15213
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Genaera Corporation
Plymouth Meeting, Pennsylvania, 19462
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701
John Moran Eye Center
Salt Lake City, Utah, 84132
Retina Associates, PA
Shawnee Mission, Kansas, 66204
East Florida Eye Institute
Stuart, Florida, 34994
Retina Associates of Florida
Tampa, Florida, 33609
Retina Associates of New Jersey
Teaneck, New Jersey, 07666
Center for Retina and Macular Disease
Winter Haven, Florida, 33880
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-Masked, Controlled Study of Squalamine Lactate (MSI-1256F) for Injection for the Treatment of Subfoveal Choroidal Neovascularization Associated With Age-Related Macular Degeneration
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.
- Conditions
- "Wet" Age-Related Macular Degeneration
- Being tested
- Squalamine Lactate
- Keywords
- wet AMD, macular degeneration
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Squalamine LactateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (4)
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
Change in area of CNV in the study eye at 52 and 104 weeks compared to baseline, as measured by fluorescein angiography
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
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2005 (estimated)
- Study startJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for "Wet" Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Genaera Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00139282
- Sponsor's protocol ID
- MSI-1256F-301
- Status last verified
- Nov 2007
- First submitted
- 29 Aug 2005
- Last updated
- 28 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-Masked, Controlled Study of Squalamine Lactate (MSI-1256F) for Injection for the Treatment of Subfoveal Choroidal Neovascularization Associated With Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT00139282
- Acronym / sponsor ID
- MSI-1256F-301
- Conditions
- "Wet" Age-Related Macular Degeneration
- Keywords
- wet AMD, macular degeneration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- Genaera CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- First posted
- 31 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a diagnosis of "wet" age-related macular degeneration
Key exclusion criteria (1 listed)
- Prior treatment for "wet" age-related macular degeneration in the affected eye in the past 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Squalamine Lactate | Drug | – |
Primary outcome
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.
4 secondary outcomes
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
Change in area of CNV in the study eye at 52 and 104 weeks compared to baseline, as measured by fluorescein angiography
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
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.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Squalamine Lactate in people with "Wet" Age-Related Macular Degeneration, run by Genaera Corporation at 29 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2007.