Clinical trial NCT02349516: Squalamine Lactate Eye Drops in Combination With Ranibizumab in Patients With Diabetic Macular Edema (DME)
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Diabetic Retinopathy
Lead sponsor: Prism Vision Group
Sponsor class: OTHER
Collaborators: name: Ohr Pharmaceutical Inc.
First posted: 2015-01-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: To explore the effect of Squalamine Lactate eye drops on Best Corrected Visual Acuity in subjects with diabetic macular edema
timeFrame: Mean change from baseline to Week 24
Secondary outcomes:
measure: To assess the change in Central Retinal Thickness
timeFrame: Change at week 24 and at week 52
measure: To assess need for rescue injections of Ranibizumab 0.3mg
timeFrame: Week 24 through week 52
measure: To assess the safety and tolerability of Squalamine Eye Drops, measured by ophthalmic examination, the recording and evaluation of clinical AEs
timeFrame: At week 24 and at Week 52
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: NJ Retina
state: New Jersey
Study officials:
affiliation: Prism Vision Group
name: Daniel Roth, MD
role: PRINCIPAL_INVESTIGATOR
References: