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

Phase 2

Withdrawn

• Conditions: Diabetic Retinopathy
• Interventions: Drug: Squalamine Lactate Ophthalmic Solution 0.2%

• Registration Number: NCT02349516
• Lead Sponsor: Starr Muscle

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.

Study Timeline

• Study First Submitted: 2014-06-02
• Study First Submitted QC: 2015-01-28
• Study First Posted: 2015-01-29
• Study Start: 2015-02
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-31
• Last Update Posted: 2016-06-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Squalamine Solution 0.2% QID	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
Squalamine Solution BID 0.2%	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	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
Vehicle Solution 0.2% QID	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

Primary Outcome Measures

Name	Time	Method
To explore the effect of Squalamine Lactate eye drops on Best Corrected Visual Acuity in subjects with diabetic macular edema	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

Secondary Outcome Measures

Name	Time	Method
To assess need for rescue injections of Ranibizumab 0.3mg	Week 24 through week 52	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	At week 24 and at Week 52	Ongoing safety assessments will include ophthalmic examination, the recording and evaluation of clinical AEs
To assess the change in Central Retinal Thickness	Change at week 24 and at week 52	Change in central retinal thickness at week 24 and at week 52

Trial Locations

Locations (1)

NJ Retina; 🇺🇸 New Brunswick, New Jersey, United States