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

Starr Muscle

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Conditions

Diabetic Retinopathy

Interventions

Squalamine Lactate Ophthalmic Solution 0.2%DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

NJ Retina

New Brunswick, New Jersey, United States

Outcomes

Primary Outcomes

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

Time frame: Mean change from baseline to Week 24

Secondary Outcomes

To assess the change in Central Retinal Thickness

Change in central retinal thickness at week 24 and at week 52

Time frame: 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

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

Ongoing safety assessments will include ophthalmic examination, the recording and evaluation of clinical AEs

Time frame: At week 24 and at Week 52

Data from ClinicalTrials.gov

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