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

NCT02349516 | Withdrawn Phase 2

• 1 other identifier: Ohr-005
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

• 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

  Mean change from baseline to Week 24

Secondary Outcomes (3)

• To assess the change in Central Retinal Thickness

  Change at week 24 and at week 52

• To assess need for rescue injections of Ranibizumab 0.3mg

  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

Study Arms (4)

Squalamine Solution BID 0.2%

EXPERIMENTAL

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%

Vehicle Solution 0.2% BID

PLACEBO COMPARATOR

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 Solution 0.2% QID

EXPERIMENTAL

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%

Vehicle Solution 0.2% QID

PLACEBO COMPARATOR

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%

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

Also known as: squalamine lactate

Squalamine Solution 0.2% QID; Squalamine Solution BID 0.2%; Vehicle Solution 0.2% BID; Vehicle Solution 0.2% QID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Starr Muscle: lead
• Ohr Pharmaceutical Inc.: collaborator

Study Sites (1)

NJ Retina

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

squalamine lactate

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Daniel Roth, MD

  Prism Vision Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, primary investigator

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: January 29, 2015
• Study Start: February 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: June 1, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)