Neovascular Age Related Macular DegenerationPhase 2NCT01678963
Efficacy and Safety of Squalamine Lactate Eye Drops in Subjects With Neovascular (Wet) Age-related Macular Degeneration (AMD)
A Phase 2 study testing Squalamine lactate in people with Neovascular Age Related Macular Degeneration, run by Ohr Pharmaceutical Inc. at 20 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of topical ophthalmic squalamine lactate eye drops in treating patients with neovascular age-related macular degeneration (wet AMD), a degenerative retinal eye disease that causes a progressive, irreversible, severe loss of central vision. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age Related Macular Degeneration
- What is being tested?
- Squalamine lactate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 20 sitesUnited States
- Study dates
- Nov 2012to Mar 2015
- 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
- ≥50 years of age, male or female
- Have the following criteria in the study eye:
- A diagnosis of choroidal neovascularization secondary to AMD with total lesion area ≤ 12 disc areas with CNV affecting at least 50% of the total lesion area, in at least one eye confirmed by fluorescein angiography (via the reading center)
- Central Retinal Thickness (SD- OCT central 1 mm) of ≥ 300 um
- Presence of sub-retinal fluid or cystoid edema on OCT. Pigment epithelial detachments without subretinal fluid or cystoid edema will be excluded
- BCVA 20/40 to 20/230 (25 to 70 letters ETDRS)
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- If both eyes qualify the eye with the greater CRT will be the study eye. If both equal the right eye will be selected as the study eye.
- Female subjects must be 1-year postmenopausal or surgically sterilized, Women of childbearing potential must have a negative urine pregnancy test and must use an acceptable method of contraception throughout the study.
- Be willing and able to provide signed informed consent prior to participation in any study-related procedures.
Who cannot join
- Neovascularization secondary to any condition other than AMD in the study eye.
- Blood occupying greater than 50% of the AMD lesion. Blood underlying the fovea.
- Prior treatment in the study eye with bevacizumab, ranibizumab, aflibercept, PDT, submacular surgery, any antiangiogenic drug.
- Confounding ocular conditions in the study eye which will affect interpretation of OCT, VA or assessment of macular appearance eg: cataract.
- Subjects with VA worse than 20/200 (less than 34 letters) in the fellow (non-study) eye.
- Fibrosis or atrophy, retinal epithelial tear in the center of the fovea in the study eye or any condition preventing VA improvement.
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- Prior ocular surgery in the study eye (Vitrectomy, scleral buckle, or glaucoma filter/shunt). Cataract surgery more than 3 months prior to enrollment is allowed so long as a posterior chamber intraocular lens is in place.
- Wearing contact lenses.
- Concomitant therapy with any drug that may affect VA, meds that may be toxic to the lens/retina or optic nerve.
- Current ocular or periocular infection in the study eye.
- Hypersensitivity to Lucentis.
- Hypersensitivity to squalamine or any component of the ophthalmic formulation
- Presence of a life threatening disease or currently on treatment for a malignancy.
- Currently on chemotherapy.
- Currently on systemic steroids.
- Pregnant or lactating.
- Investigational product use of any kind in the previous 30 days.
- Subjects for whom attendance for monthly examinations may be unreliable eg: dependent on an elderly caregiver.
- Glaucoma in the study eye (glaucomatous visual field defect and receiving treatment).
- Myocardial infarction or cerebrovascular accident or transient ischemic attacks (TIA) within the past 6 months.
- Clinical evidence of diabetic retinopathy or diabetic macular edema in the study eye.
- Uncontrolled hypertension (Diastolic BP >105 mmHg) in spite of antihypertensive medications.
- Subjects known to have HIV.
- A history of drug or alcohol abuse.
- Subjects unable to administer eye drops reliably.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
California Retinal Consultants
Bakersfield, California, 93309
Elman Retina
Baltimore, Maryland, 21237
Retina-Vitreous Associates
Beverly Hilss, California, 90211
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
Florida Eye Microsurgical Institute Inc.
Boynton Beach, Florida, 33426
PA Retina
Camp Hill, Pennsylvania, 17011
Retina Associates of Cleveland
Cleveland, Ohio, 44122
Retina Health Center
Fort Myers, Florida, 33907
Colorado Retina
Golden, Colorado, 80401
Vision Research Foundation
Grand Rapids, Michigan, 49546
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740
Midwest Eye Institute
Indianapolis, Indiana, 46290
University of Wisconsin
Madison, Wisconsin, 53705
TN Retina
Nashville, Tennessee, 37203
Total Practice Management
New Brunswick, New Jersey, 08901
Macula Care
New York, New York, 10021
Vision Research Foundation
Royal Oak, Michigan, 48073
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240
Vision Research Foundation
Traverse City, Michigan, 49686
Retina Associates SW
Tucson, Arizona, 85710
About this study
Official title: Phase II Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Formulation 0.2% BID in Subjects With Neovascular AMD.
The purpose of this study is to evaluate the safety and efficacy of topical ophthalmic squalamine lactate eye drops in treating patients with neovascular age-related macular degeneration (wet AMD), a degenerative retinal eye disease that causes a progressive, irreversible, severe loss of central vision.
Read the detailed description
Age-related macular degeneration (AMD) is a degenerative retinal eye disease 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 and affects 25-30 million people globally. This number is expected to triple over the next 25 years. Central vision loss from AMD is caused by the degeneration of light-sensing cells in the macula called photoreceptors. The macula, the central portion of the retina, is responsible for perceiving fine visual detail. As photoreceptors begin to degenerate, so does the individual's central vision. The extent of vision loss varies widely and is related to the type of AMD, its severity and other individual characteristics.
AMD presents itself in two different forms - a "dry" form and the more severe "wet" form. Dry AMD, the more common and milder form of AMD, accounts for 85% to 90% of all cases. It results in varying forms of sight loss and may or may not eventually develop into the wet form. Although the wet form of AMD accounts for only 10% to 15% of all AMD, the chance for severe sight loss is much greater. Wet AMD is responsible for 90% of severe vision loss associated with AMD. Approximately 500,000 new cases of wet AMD are diagnosed annually worldwide. In North America alone, approximately 200,000 new cases of wet AMD are diagnosed each year.
Squalamine lactate has been found to be an inhibitor of new blood vessel formation (angiogenesis) induced by VEGF, PDGF or bFGF. Since angiogenesis is implicated in the growth and maintenance of choroidal neovascularization, squalamine lactate is potentially an attractive development candidate in the treatment of age-related macular degeneration (AMD), in which blood vessel proliferation has a role.
- Being tested
- Squalamine lactate, Vehicle control
- Keywords
- Neovascular AMD, Wet AMD, AMD, Age related 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
Ophthalmic solution 0.2%
Vehicle controlDrug
Ophthalmic solution vehicle control
| Study group | Role | What they receive |
|---|---|---|
| Squalamine | Experimental | Squalamine eye drop 0.2% Receives: Drug: Squalamine lactate |
| Vehicle Control | Placebo comparator | Eye drop vehicle control Receives: Drug: Vehicle control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for continued concomitant therapy
Lucentis (ranibizumab) is the current standard of care for the treatment of wet AMD. All patients will receive an initial injection of Lucentis prior to randomization and then be evaluated monthly for their need for further Lucentis injections using protocol defined retreatment criteria.
Measured: 9 months
Secondary outcomes (2)
Best Corrected Visual Acuity (BCVA)
Evaluation of the effect of treatment on visual function (BCVA) as measured using the EDTRS chart measured at an initial distance of 4 meters.
Measured: 9 months
Number of subjects with adverse events as a measure of safety and tolerability
The frequency, severity, seriousness of all adverse events including their relationship to study drug and effect on discontinuation from the study will be monitored, recorded and analysed.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2012 (estimated)
- Study startNov 2012
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohr Pharmaceutical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01678963
- Sponsor's protocol ID
- OHR-002
- Status last verified
- Jun 2015
- First submitted
- 27 Aug 2012
- Last updated
- 12 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Formulation 0.2% BID in Subjects With Neovascular AMD.
- ClinicalTrials.gov ID
- NCT01678963
- Acronym / sponsor ID
- OHR-002
- Keywords
- Neovascular AMD, Wet AMD, AMD, Age related macular degeneration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Ohr Pharmaceutical Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 5 Sep 2012 (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.
The purpose of this study is to evaluate the safety and efficacy of topical ophthalmic squalamine lactate eye drops in treating patients with neovascular age-related macular degeneration (wet AMD), a degenerative retinal eye disease that causes a progressive, irreversible, severe loss of central vision.
Detailed description
Age-related macular degeneration (AMD) is a degenerative retinal eye disease 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 and affects 25-30 million people globally. This number is expected to triple over the next 25 years. Central vision loss from AMD is caused by the degeneration of light-sensing cells in the macula called photoreceptors. The macula, the central portion of the retina, is responsible for perceiving fine visual detail. As photoreceptors begin to degenerate, so does the individual's central vision. The extent of vision loss varies widely and is related to the type of AMD, its severity and other individual characteristics.
AMD presents itself in two different forms - a "dry" form and the more severe "wet" form. Dry AMD, the more common and milder form of AMD, accounts for 85% to 90% of all cases. It results in varying forms of sight loss and may or may not eventually develop into the wet form. Although the wet form of AMD accounts for only 10% to 15% of all AMD, the chance for severe sight loss is much greater. Wet AMD is responsible for 90% of severe vision loss associated with AMD. Approximately 500,000 new cases of wet AMD are diagnosed annually worldwide. In North America alone, approximately 200,000 new cases of wet AMD are diagnosed each year.
Squalamine lactate has been found to be an inhibitor of new blood vessel formation (angiogenesis) induced by VEGF, PDGF or bFGF. Since angiogenesis is implicated in the growth and maintenance of choroidal neovascularization, squalamine lactate is potentially an attractive development candidate in the treatment of age-related macular degeneration (AMD), in which blood vessel proliferation has a role.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Squalamine | Experimental | Drug: Squalamine lactateSqualamine eye drop 0.2% |
| Vehicle Control | Placebo comparator | Drug: Vehicle controlEye drop vehicle control |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ≥50 years of age, male or female
- Have the following criteria in the study eye:
- Female subjects must be 1-year postmenopausal or surgically sterilized, Women of childbearing potential must have a negative urine pregnancy test and must use an acceptable method of contraception throughout the study.
- Be willing and able to provide signed informed consent prior to participation in any study-related procedures.
Key exclusion criteria (25 listed)
- Neovascularization secondary to any condition other than AMD in the study eye.
- Blood occupying greater than 50% of the AMD lesion. Blood underlying the fovea.
- Prior treatment in the study eye with bevacizumab, ranibizumab, aflibercept, PDT, submacular surgery, any antiangiogenic drug.
- Confounding ocular conditions in the study eye which will affect interpretation of OCT, VA or assessment of macular appearance eg: cataract.
- Subjects with VA worse than 20/200 (less than 34 letters) in the fellow (non-study) eye.
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 lactateOphthalmic solution 0.2% | Drug | Squalamine |
| Vehicle controlOphthalmic solution vehicle control | Drug | Vehicle Control |
Primary outcome
Need for continued concomitant therapy
Time frame: 9 months
Lucentis (ranibizumab) is the current standard of care for the treatment of wet AMD. All patients will receive an initial injection of Lucentis prior to randomization and then be evaluated monthly for their need for further Lucentis injections using protocol defined retreatment criteria.
2 secondary outcomes
Best Corrected Visual Acuity (BCVA)
Time frame: 9 months
Number of subjects with adverse events as a measure of safety and tolerability
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2015.
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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.
20 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 Squalamine lactate in people with Neovascular Age Related Macular Degeneration, run by Ohr Pharmaceutical Inc. at 20 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 9 inclusion and 25 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: finished, as of the sponsor's last update on 12 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Need for continued concomitant therapy (time frame: 9 months). 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 12 Jun 2015.