Diabetic RetinopathyPhase 2NCT02349516
Squalamine Lactate Eye Drops in Combination With Ranibizumab in Patients With Diabetic Macular Edema (DME)
A Phase 2 study testing Squalamine Lactate Ophthalmic Solution 0.2% in people with Diabetic Retinopathy, run by Starr Muscle at 1 site in United States.
Trial summary
A randomized, controlled study of the safety and efficacy of Squalamine Lactate Eye Drops in combination with Ranibizumab intravitreal injections in patients with diabetic macular edema. The study duration is 52 weeks and patients will be randomized to one of four treatment arms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Squalamine Lactate Ophthalmic Solution 0.2%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will have clinically significant diabetic macular edema of ≥ 300 microns with central involvement using the Heidelberg or Cirrus machine
- Best corrected visual acuity of 20/32 to 20/320 inclusive in the study eye
- Adults ≥ 18 years of age with type 1 or 2 diabetes mellitus with diabetic macular edema
Who cannot join
- History of vitreoretinal surgery in the study eye
- Panretinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of screening
- Any prior laser in study eye
- Previous use of intraocular or periocular corticosteroids in the study eye within 6 months of screening
- Previous treatment with anti-angiogenic drugs in either eye within 3 months of screening
- Uncontrolled diabetes mellitus with HbA1c levels greater than 12
- Ocular disorders in the study eye, other than diabetic macular edema, that my confound interpretation of study results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled Study of the Safety and Efficacy of Squalamine Lactate Eye Drops in Combination With Ranibizumab in Patients With Diabetic Macular Edema
A randomized, controlled study of the safety and efficacy of Squalamine Lactate Eye Drops in combination with Ranibizumab intravitreal injections in patients with diabetic macular edema. The study duration is 52 weeks and patients will be randomized to one of four treatment arms.
Read the detailed description
A randomized, controlled study of the safety and efficacy of Squalamine Lactate eye drops in combination with Ranibizumab intravitreal injections in patients with diabetic macular edema. Subjects will be randomized to one of the following treatment arms:
- Squalamine Lactate Ophthalmic Solution administered twice a day for 52 weeks in combination with monthly injections of ranibizumab from baseline through week 20 and ranibizumab as needed from week 24 through week 52.
- Vehicle Ophthalmic Solution administered twice a day for 52 weeks in combination with monthly injection of ranibizumab from baseline through week 20 and ranibizumab as needed from week 24 through week 52.
- Squalamine Lactate Ophthalmic Solution administered four times a day for 52 weeks in combination with monthly injections of ranibizumab from baseline through week 20 and ranibizumab as needed from week 24 through week 52.
- Vehicle Ophthalmic Solution administered four times a day for 52 weeks in combination with monthly injection of ranibizumab from baseline through week 20 and ranibizumab as needed from week 24 through week 52.
- Conditions
- Diabetic Retinopathy
- Being tested
- Squalamine Lactate Ophthalmic Solution 0.2%
- Medical subject headings
- Diabetic Retinopathy
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 lactate
Squalamine Lactate Ophthalmic Solution 0.2% eye drop to be administered to study eye either BID or QID for 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| Squalamine Solution BID 0.2% | Experimental | Squalamine Lactate Ophthalmic Solution 0.2% administered twice a day for 52 weeks in combination with monthly intravitreal injections of ranibizumab 0.3mg from baseline through week 20 and ranibizumab as needed from week 24 through week 52 Receives: Drug: Squalamine Lactate Ophthalmic Solution 0.2% |
| Vehicle Solution 0.2% BID | Placebo comparator | Vehicle Ophthalmic Solution 0.2% administered twice a day for 52 weeks in combination with monthly intravitreal injections of ranibizumab 0.3mg from baseline through week 20 and ranbizumab as needed from week 24 through week 52 Receives: Drug: Squalamine Lactate Ophthalmic Solution 0.2% |
| Squalamine Solution 0.2% QID | Experimental | Squalamine Lactate Ophthalmic Solution 0.2% administered four times a day for 52 weeks in combination with monthly intravitreal injections of ranibizumab 0.3mg from baseline through week 20 and ranibizumab as needed from week 24 through week 52 Receives: Drug: Squalamine Lactate Ophthalmic Solution 0.2% |
| Vehicle Solution 0.2% QID | Placebo comparator | Vehicle Ophthalmic Solution 0.2% administered four times a day for 52 weeks in combination with monthly intravitreal injections of ranibizumab 0.3mg from baseline through week 20 and ranbizumab as needed from week 24 through week 52 Receives: Drug: Squalamine Lactate Ophthalmic Solution 0.2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
To explore the effect of Squalamine Lactate eye drops on Best Corrected Visual Acuity in subjects with diabetic macular edema
Proportion of patients gaining at least 3,4 and 5 lines in best corrected visual acuity from baseline to week 24
Measured: Mean change from baseline to Week 24
Secondary outcomes (3)
To assess the change in Central Retinal Thickness
Change in central retinal thickness at week 24 and at week 52
Measured: Change at week 24 and at week 52
To assess need for rescue injections of Ranibizumab 0.3mg
To assess the number of rescue (as needed) ranibizumab re-treatments from week 24 through week 52
Measured: Week 24 through week 52
To assess the safety and tolerability of Squalamine Eye Drops, measured by ophthalmic examination, the recording and evaluation of clinical AEs
Ongoing safety assessments will include ophthalmic examination, the recording and evaluation of clinical AEs
Measured: At week 24 and at Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: Study cancelled as of 9/12/15. 0 subjects enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Starr Muscle
- Sponsor type
- University, hospital or other
- Collaborators
- Ohr Pharmaceutical Inc.
- Responsible party
- Sponsor-investigator, Starr Muscle, Prism Vision Group
- Investigators
- Daniel Roth, MD, Principal investigator, Prism Vision Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02349516
- Sponsor's protocol ID
- Ohr-005
- Status last verified
- May 2016
- First submitted
- 2 Jun 2014
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Study cancelled, no data
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Study of the Safety and Efficacy of Squalamine Lactate Eye Drops in Combination With Ranibizumab in Patients With Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT02349516
- Acronym / sponsor ID
- Ohr-005
- Conditions
- Diabetic Retinopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study cancelled as of 9/12/15. 0 subjects enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Starr MuscleUniversity, hospital or other
- Collaborators
- Ohr Pharmaceutical Inc.
- Study start
- Feb 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 29 Jan 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.
A randomized, controlled study of the safety and efficacy of Squalamine Lactate Eye Drops in combination with Ranibizumab intravitreal injections in patients with diabetic macular edema. The study duration is 52 weeks and patients will be randomized to one of four treatment arms.
Detailed description
A randomized, controlled study of the safety and efficacy of Squalamine Lactate eye drops in combination with Ranibizumab intravitreal injections in patients with diabetic macular edema. Subjects will be randomized to one of the following treatment arms:
- Squalamine Lactate Ophthalmic Solution administered twice a day for 52 weeks in combination with monthly injections of ranibizumab from baseline through week 20 and ranibizumab as needed from week 24 through week 52.
- Vehicle Ophthalmic Solution administered twice a day for 52 weeks in combination with monthly injection of ranibizumab from baseline through week 20 and ranibizumab as needed from week 24 through week 52.
- Squalamine Lactate Ophthalmic Solution administered four times a day for 52 weeks in combination with monthly injections of ranibizumab from baseline through week 20 and ranibizumab as needed from week 24 through week 52.
- Vehicle Ophthalmic Solution administered four times a day for 52 weeks in combination with monthly injection of ranibizumab from baseline through week 20 and ranibizumab as needed from week 24 through week 52.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Squalamine Solution BID 0.2% | Experimental | Drug: Squalamine Lactate Ophthalmic Solution 0.2%Squalamine Lactate Ophthalmic Solution 0.2% administered twice a day for 52 weeks in combination with monthly intravitreal injections of ranibizumab 0.3mg from baseline through week 20 and ranibizumab as needed from week 24 through week 52 |
| Vehicle Solution 0.2% BID | Placebo comparator | Drug: Squalamine Lactate Ophthalmic Solution 0.2%Vehicle Ophthalmic Solution 0.2% administered twice a day for 52 weeks in combination with monthly intravitreal injections of ranibizumab 0.3mg from baseline through week 20 and ranbizumab as needed from week 24 through week 52 |
| Squalamine Solution 0.2% QID | Experimental | Drug: Squalamine Lactate Ophthalmic Solution 0.2%Squalamine Lactate Ophthalmic Solution 0.2% administered four times a day for 52 weeks in combination with monthly intravitreal injections of ranibizumab 0.3mg from baseline through week 20 and ranibizumab as needed from week 24 through week 52 |
| Vehicle Solution 0.2% QID | Placebo comparator | Drug: Squalamine Lactate Ophthalmic Solution 0.2%Vehicle Ophthalmic Solution 0.2% administered four times a day for 52 weeks in combination with monthly intravitreal injections of ranibizumab 0.3mg from baseline through week 20 and ranbizumab as needed from week 24 through week 52 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects will have clinically significant diabetic macular edema of ≥ 300 microns with central involvement using the Heidelberg or Cirrus machine
- Best corrected visual acuity of 20/32 to 20/320 inclusive in the study eye
- Adults ≥ 18 years of age with type 1 or 2 diabetes mellitus with diabetic macular edema
Key exclusion criteria (7 listed)
- History of vitreoretinal surgery in the study eye
- Panretinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of screening
- Any prior laser in study eye
- Previous use of intraocular or periocular corticosteroids in the study eye within 6 months of screening
- Previous treatment with anti-angiogenic drugs in either eye within 3 months of screening
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: squalamine lactateSqualamine Lactate Ophthalmic Solution 0.2% eye drop to be administered to study eye either BID or QID for 52 weeks | Drug | Squalamine Solution 0.2% QID, Squalamine Solution BID 0.2%, Vehicle Solution 0.2% BID, Vehicle Solution 0.2% QID |
Primary outcome
To explore the effect of Squalamine Lactate eye drops on Best Corrected Visual Acuity in subjects with diabetic macular edema
Time frame: Mean change from baseline to Week 24
Proportion of patients gaining at least 3,4 and 5 lines in best corrected visual acuity from baseline to week 24
3 secondary outcomes
To assess the change in Central Retinal Thickness
Time frame: Change at week 24 and at week 52
To assess need for rescue injections of Ranibizumab 0.3mg
Time frame: Week 24 through week 52
To assess the safety and tolerability of Squalamine Eye Drops, measured by ophthalmic examination, the recording and evaluation of clinical AEs
Time frame: At week 24 and at Week 52
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 1 Jun 2016.
- Individual participant dataSharing planned: No. Study cancelled, no data
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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.
Daniel Roth, MD principal investigator
Prism Vision Group
1 site 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% in people with Diabetic Retinopathy, run by Starr Muscle at 1 site 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 3 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 1 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
To explore the effect of Squalamine Lactate eye drops on Best Corrected Visual Acuity in subjects with diabetic macular edema (time frame: Mean change from baseline to Week 24). 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 1 Jun 2016.