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Squalamine Lactate Eye Drops in Combination With Ranibizumab in Patients With Diabetic Macular Edema (DME)

Primary Purpose

Diabetic Retinopathy

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Squalamine Lactate Ophthalmic Solution 0.2%
Sponsored by
Starr Muscle
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Retinopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • NJ Retina

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Squalamine Solution BID 0.2%

Vehicle Solution 0.2% BID

Squalamine Solution 0.2% QID

Vehicle Solution 0.2% QID

Arm Description

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 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 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 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To assess the change in Central Retinal Thickness
Change in central retinal thickness 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
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

Full Information

First Posted
June 2, 2014
Last Updated
May 31, 2016
Sponsor
Starr Muscle
Collaborators
Ohr Pharmaceutical Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02349516
Brief Title
Squalamine Lactate Eye Drops in Combination With Ranibizumab in Patients With Diabetic Macular Edema (DME)
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Study cancelled as of 9/12/15. 0 subjects enrolled.
Study Start Date
February 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Starr Muscle
Collaborators
Ohr Pharmaceutical Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Squalamine Solution BID 0.2%
Arm Type
Experimental
Arm Description
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
Arm Title
Vehicle Solution 0.2% BID
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Squalamine Solution 0.2% QID
Arm Type
Experimental
Arm Description
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
Arm Title
Vehicle Solution 0.2% QID
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Squalamine Lactate Ophthalmic Solution 0.2%
Other Intervention Name(s)
squalamine lactate
Intervention Description
Squalamine Lactate Ophthalmic Solution 0.2% eye drop to be administered to study eye either BID or QID for 52 weeks
Primary Outcome Measure Information:
Title
To explore the effect of Squalamine Lactate eye drops on Best Corrected Visual Acuity in subjects with diabetic macular edema
Description
Proportion of patients gaining at least 3,4 and 5 lines in best corrected visual acuity from baseline to week 24
Time Frame
Mean change from baseline to Week 24
Secondary Outcome Measure Information:
Title
To assess the change in Central Retinal Thickness
Description
Change in central retinal thickness at week 24 and at week 52
Time Frame
Change at week 24 and at week 52
Title
To assess need for rescue injections of Ranibizumab 0.3mg
Description
To assess the number of rescue (as needed) ranibizumab re-treatments from week 24 through week 52
Time Frame
Week 24 through week 52
Title
To assess the safety and tolerability of Squalamine Eye Drops, measured by ophthalmic examination, the recording and evaluation of clinical AEs
Description
Ongoing safety assessments will include ophthalmic examination, the recording and evaluation of clinical AEs
Time Frame
At week 24 and at Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Roth, MD
Organizational Affiliation
Prism Vision Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
NJ Retina
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Study cancelled, no data

Learn more about this trial

Squalamine Lactate Eye Drops in Combination With Ranibizumab in Patients With Diabetic Macular Edema (DME)

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