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

NCT ID: NCT02349516

Last Updated: 2016-06-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2015-09-30

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:

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.

Conditions

Diabetic Retinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

Squalamine Lactate Ophthalmic Solution 0.2%

Intervention Type: DRUG

Squalamine Lactate Ophthalmic Solution 0.2% eye drop to be administered to study eye either BID or QID for 52 weeks

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

Group Type: PLACEBO_COMPARATOR

Squalamine Lactate Ophthalmic Solution 0.2%

Intervention Type: DRUG

Squalamine Lactate Ophthalmic Solution 0.2% eye drop to be administered to study eye either BID or QID for 52 weeks

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

Group Type: EXPERIMENTAL

Squalamine Lactate Ophthalmic Solution 0.2%

Intervention Type: DRUG

Squalamine Lactate Ophthalmic Solution 0.2% eye drop to be administered to study eye either BID or QID for 52 weeks

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

Group Type: PLACEBO_COMPARATOR

Squalamine Lactate Ophthalmic Solution 0.2%

Intervention Type: DRUG

Squalamine Lactate Ophthalmic Solution 0.2% eye drop to be administered to study eye either BID or QID for 52 weeks

Interventions

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

Intervention Type: DRUG

Other Intervention Names

squalamine lactate

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohr Pharmaceutical Inc.

INDUSTRY

Sponsor Role: collaborator

Starr Muscle

OTHER

Sponsor Role: lead

Responsible Party

Starr Muscle

MD, primary investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Daniel Roth, MD

Role: PRINCIPAL_INVESTIGATOR

Prism Vision Group

Locations

NJ Retina

New Brunswick, New Jersey, United States

Countries

United States

Other Identifiers

Ohr-005

Identifier Type: -

Identifier Source: org_study_id