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

Diabetic Retinopathy Clinical Trial

Official title:

A Randomized, Controlled Study of the Safety and Efficacy of Squalamine Lactate Eye Drops in Combination With Ranibizumab in Patients With Diabetic Macular Edema

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02349516
• Other study ID #: Ohr-005
• Status: Withdrawn
• Phase: Phase 2
• First received: June 2, 2014
• Last updated: May 31, 2016
• Start date: February 2015
• Est. completion date: September 2015

Study information

• Verified date: May 2016
• Source: NJ Retina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Macular Edema

Intervention

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

Locations

Country	Name	City	State
United States	NJ Retina	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Starr Muscle	Ohr Pharmaceutical Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To assess the change in Central Retinal Thickness	Change in central retinal thickness at week 24 and at week 52	Change at week 24 and at week 52	No
Secondary	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	Week 24 through week 52	No
Secondary	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	At week 24 and at Week 52	Yes