Age-Related Macular DegenerationPhase 2NCT02511613
Effect of Squalamine Lactate Ophthalmic Solution, 0.2% in Subjects With Neovascular Age-Related Macular Degeneration
A Phase 2 study testing Squalamine Lactate Ophthalmic Solution, 0.2% and ranibizumab in people with Age-Related Macular Degeneration, run by Ohr Pharmaceutical Inc. at 4 sites in United States.
Trial summary
The purpose of this study is to evaluate anatomical and functional effect of combination therapy of Squalamine Lactate Ophthalmic Solution, 0.2% administered twice daily with monthly ranibizumab intravitreal injections in patients with choroidal neovascularization due to AMD. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- Squalamine Lactate Ophthalmic Solution, 0.2% and ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2015to Apr 2016
- 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 or older
- A diagnosis of choroidal neovascularization secondary to age-related macular degeneration (AMD) with choroidal neovascularization (CNV) comprising at least 50% of the total lesion area in the study eye
- Central retinal thickness ≥ 300 μm and presence of subretinal fluid or cystoid edema by Optical Coherence Tomography (OCT)
- Best Corrected Visual Acuity (BCVA) of 20/40 to 20/320 by Early Treatment Diabetic Retinopathy Study (ETDRS) Protocol
Who cannot join
- Neovascularization secondary to any other condition than AMD in the study eye
- Blood occupying greater than 50% of the AMD lesion, or blood > 1.0 sq. mm underlying the fovea
- PED without associated subretinal fluid and/or cystic retinal changes
- Clinical evidence of diabetic retinopathy or diabetic macular edema in the study eye
- Confounding ocular conditions in the study eye which will affect interpretation of OCT, VA or assessment of macular appearance (e.g., cataract, epiretinal membrane, retinal vascular occlusive disease)
- Fibrosis or atrophy, retinal epithelial tear in the center of the fovea in the study eye or any condition preventing VA improvement
- Uncontrolled glaucoma in the study eye, or currently receiving topical glaucoma medication in the study eye
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Investigational Site
Beverly Hills, California, 90211
Investigational Site
Hagerstown, Maryland, 21740
Investigational Site
Houston, Texas, 77030
Investigational Site
New York, New York, 10022
About this study
Official title: A Study of Safety, Functional and Anatomical Effect of Squalamine Lactate Ophthalmic Solution, 0.2% Administered Twice Daily in Subjects With Neovascular Age-related Macular Degeneration
The purpose of this study is to evaluate anatomical and functional effect of combination therapy of Squalamine Lactate Ophthalmic Solution, 0.2% administered twice daily with monthly ranibizumab intravitreal injections in patients with choroidal neovascularization due to AMD.
Read the detailed description
Subjects with age-related macular degeneration who meet inclusion and exclusion criteria will be randomized to receive monthly intravitreal injections of ranibizumab (Lucentis®) with either Squalamine Lactate Ophthalmic solution 0.2% or placebo eye drops twice a day for 6 months. Subjects will be evaluated with clinical and imaging techniques.
- Conditions
- Age-Related Macular Degeneration
- Being tested
- Squalamine Lactate Ophthalmic Solution, 0.2%, Placebo Ophthalmic Solution, ranibizumab
- 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 Lactate Ophthalmic Solution, 0.2%Drug
Also called Squalamine
Squalamine Lactate Ophthalmic Solution, 0.2% administered BID
Placebo Ophthalmic SolutionDrug
Also called Placebo
Placebo Ophthalmic Solution, administered BID
ranibizumabDrug
Also called Lucentis®
ranibizumab intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Monthly intravitreal ranibizumab plus Placebo Ophthalmic solution Receives: Drug: Placebo Ophthalmic Solution; Drug: ranibizumab |
| Active | Active comparator | Monthly intravitreal ranibizumab plus Squalamine Lactate Ophthalmic solution 0.2% Receives: Drug: Squalamine Lactate Ophthalmic Solution, 0.2%; Drug: ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of combination therapy of ranibizumab monthly intravitreal injections with Squalamine Lactate Ophthalmic Solution, 0.2% on anatomy and function as assessed by retinal imaging and ETDRS BCVA in subjects with Age-Related Macular Degeneration
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Why it stopped: Company decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohr Pharmaceutical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Avner Ingerman, MD, Study director, Ohr Pharmaceutical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02511613
- Sponsor's protocol ID
- OHR-1501
- Status last verified
- Apr 2017
- First submitted
- 27 Jul 2015
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Safety, Functional and Anatomical Effect of Squalamine Lactate Ophthalmic Solution, 0.2% Administered Twice Daily in Subjects With Neovascular Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT02511613
- Acronym / sponsor ID
- OHR-1501
- Conditions
- Age-Related Macular Degeneration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Company decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ohr Pharmaceutical Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 30 Jul 2015 (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 anatomical and functional effect of combination therapy of Squalamine Lactate Ophthalmic Solution, 0.2% administered twice daily with monthly ranibizumab intravitreal injections in patients with choroidal neovascularization due to AMD.
Detailed description
Subjects with age-related macular degeneration who meet inclusion and exclusion criteria will be randomized to receive monthly intravitreal injections of ranibizumab (Lucentis®) with either Squalamine Lactate Ophthalmic solution 0.2% or placebo eye drops twice a day for 6 months. Subjects will be evaluated with clinical and imaging techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo Ophthalmic Solution, Drug: ranibizumabMonthly intravitreal ranibizumab plus Placebo Ophthalmic solution |
| Active | Active comparator | Drug: Squalamine Lactate Ophthalmic Solution, 0.2%, Drug: ranibizumabMonthly intravitreal ranibizumab plus Squalamine Lactate Ophthalmic solution 0.2% |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 50 years of age or older
- A diagnosis of choroidal neovascularization secondary to age-related macular degeneration (AMD) with choroidal neovascularization (CNV) comprising at least 50% of the total lesion area in the study eye
- Central retinal thickness ≥ 300 μm and presence of subretinal fluid or cystoid edema by Optical Coherence Tomography (OCT)
- Best Corrected Visual Acuity (BCVA) of 20/40 to 20/320 by Early Treatment Diabetic Retinopathy Study (ETDRS) Protocol
Key exclusion criteria (7 listed)
- Neovascularization secondary to any other condition than AMD in the study eye
- Blood occupying greater than 50% of the AMD lesion, or blood > 1.0 sq. mm underlying the fovea
- PED without associated subretinal fluid and/or cystic retinal changes
- Clinical evidence of diabetic retinopathy or diabetic macular edema in the study eye
- Confounding ocular conditions in the study eye which will affect interpretation of OCT, VA or assessment of macular appearance (e.g., cataract, epiretinal membrane, retinal vascular occlusive disease)
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 Ophthalmic Solution, 0.2%Also: SqualamineSqualamine Lactate Ophthalmic Solution, 0.2% administered BID | Drug | Active |
| Placebo Ophthalmic SolutionAlso: PlaceboPlacebo Ophthalmic Solution, administered BID | Drug | Placebo |
| ranibizumabAlso: Lucentis®ranibizumab intravitreal injection | Drug | Active, Placebo |
Primary outcome
Effect of combination therapy of ranibizumab monthly intravitreal injections with Squalamine Lactate Ophthalmic Solution, 0.2% on anatomy and function as assessed by retinal imaging and ETDRS BCVA in subjects with Age-Related Macular Degeneration
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
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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.
Avner Ingerman, MD study director
Ohr Pharmaceutical
4 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 Ophthalmic Solution, 0.2% and ranibizumab in people with Age-Related Macular Degeneration, run by Ohr Pharmaceutical Inc. at 4 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 4 inclusion and 7 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: withdrawn, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 was withdrawn before enrolling participants, so there are no results.
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?
Effect of combination therapy of ranibizumab monthly intravitreal injections with Squalamine Lactate Ophthalmic Solution, 0.2% on anatomy and function as assessed by retinal imaging and ETDRS BCVA in subjects with Age-Related Macular Degeneration (time frame: 6 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 27 Apr 2017.