Macular DegenerationPhase 2NCT00333476
A Study of MSI-1256F (Squalamine Lactate) To Treat "Wet" Age-Related Macular Degeneration
A Phase 2 study testing MSI-1256F (Squalamine Lactate) in people with Macular Degeneration, run by Genaera Corporation at 9 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 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- MSI-1256F (Squalamine Lactate)
- How many people
- 140 participants
- Where
- 9 sitesUnited States
- Study dates
- May 2006to not given
- Phase
- Phase 2
- 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
- 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.
Who cannot join
- Previous history of triamcinolone, bevacizumab, ranibizumab, or pegaptanib sodium injection therapy in the study eye.
- retinal or optic nerve disease.
- uncontrolled diabetes.
- ongoing malignancy.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Florida Eye Microsurgical Institute
Boynton Beach, Florida, 33426
Retina Health Center
Fort Meyers, Florida, 33907
Charles Garcia, MD, P.A.
Houston, Texas, 77002
Midwest Eye Institute
Indianapolis, Indiana, 46280
Eye Foundation of Kansas City
Kansas City, Missouri, 64108
Ophthalmic Consultants of Long Island
Long Island City, New York, 11563
Bascom Palmer Eye Institute
Miami, Florida, 33136
Retina Associates of Western New York
Rochester, New York, 14618
Retina Specialists
Towson, Maryland, 21204
About this study
Official title: 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
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.
- Conditions
- Macular Degeneration
- Being tested
- MSI-1256F (Squalamine Lactate)
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSI-1256F (Squalamine Lactate)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2006 (estimated)
- Study startMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants
Sponsor and investigators
- Lead sponsor
- Genaera Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Randy Katz, MD, Principal investigator, Florida Eye Microsurgical Institute, Inc.Alexander Eaton, MD, Principal investigator, Retina Health CenterThomas Ciulla, MD, Principal investigator, Midwest Eye InstituteRaymond Sjaarda, MD, Principal investigator, Retina SpecialistsNelson Sabates, MD, Principal investigator, Eye Foundation of Kansas CityCharles Garcia, MD, Principal investigator, Charles Garcia, MD, P.A.Glenn Stoller, MD, Principal investigator, Ophthalmic Consultants of Long IslandPhillip Rosenfeld, MD, Principal investigator, Bascom Palmer Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00333476
- Sponsor's protocol ID
- MSI-1256F-212
- Status last verified
- Nov 2007
- First submitted
- 1 Jun 2006
- 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 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
- ClinicalTrials.gov ID
- NCT00333476
- Acronym / sponsor ID
- MSI-1256F-212
- Conditions
- Macular Degeneration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 140 participants
- Lead sponsor
- Genaera CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2006
- First posted
- 5 Jun 2006 (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 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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- Previous history of triamcinolone, bevacizumab, ranibizumab, or pegaptanib sodium injection therapy in the study eye.
- retinal or optic nerve disease.
- uncontrolled diabetes.
- ongoing malignancy.
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 |
|---|---|---|
| MSI-1256F (Squalamine Lactate) | Drug | – |
Primary outcome
To evaluate the safety profile of squalamine lactate at doses ranging from 40 mg to 160 mg of squalamine lactate
2 secondary outcomes
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
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.
Randy Katz, MD principal investigator
Florida Eye Microsurgical Institute, Inc.
Alexander Eaton, MD principal investigator
Retina Health Center
Thomas Ciulla, MD principal investigator
Midwest Eye Institute
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MSI-1256F (Squalamine Lactate) in people with Macular Degeneration, run by Genaera Corporation at 9 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 6 inclusion and 4 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 9 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To evaluate the safety profile of squalamine lactate at doses ranging from 40 mg to 160 mg of squalamine lactate. 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.