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

May 31, 2016 updated by: Starr Muscle

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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:

  1. 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.
  2. 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.
  3. 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.
  4. 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 Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • NJ Retina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Squalamine Solution BID 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
Drug: Squalamine Lactate Ophthalmic Solution 0.2%
Squalamine Lactate Ophthalmic Solution 0.2% eye drop to be administered to study eye either BID or QID for 52 weeks
Other Names:
  • squalamine lactate
Placebo Comparator: Vehicle Solution 0.2% BID
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
Drug: Squalamine Lactate Ophthalmic Solution 0.2%
Squalamine Lactate Ophthalmic Solution 0.2% eye drop to be administered to study eye either BID or QID for 52 weeks
Other Names:
  • squalamine lactate
Experimental: Squalamine Solution 0.2% QID
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
Drug: Squalamine Lactate Ophthalmic Solution 0.2%
Squalamine Lactate Ophthalmic Solution 0.2% eye drop to be administered to study eye either BID or QID for 52 weeks
Other Names:
  • squalamine lactate
Placebo Comparator: Vehicle Solution 0.2% QID
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
Drug: Squalamine Lactate Ophthalmic Solution 0.2%
Squalamine Lactate Ophthalmic Solution 0.2% eye drop to be administered to study eye either BID or QID for 52 weeks
Other Names:
  • squalamine lactate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Mean change from baseline to Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the change in Central Retinal Thickness
Time Frame: Change at week 24 and at week 52
Change in central retinal thickness at week 24 and at week 52
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 number of rescue (as needed) ranibizumab re-treatments from week 24 through week 52
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
Ongoing safety assessments will include ophthalmic examination, the recording and evaluation of clinical AEs
At week 24 and at Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Starr Muscle

Collaborators

Ohr Pharmaceutical Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

June 2, 2014

First Submitted That Met QC Criteria

January 28, 2015

First Posted (Estimate)

January 29, 2015

Study Record Updates

Last Update Posted (Estimate)

June 1, 2016

Last Update Submitted That Met QC Criteria

May 31, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ohr-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Study cancelled, no data

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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