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

Starr Muscle

Status and phase: Withdrawn; Phase 2

Conditions: Diabetic Retinopathy

Treatments: Drug: Squalamine Lactate Ophthalmic Solution 0.2%

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02349516

Ohr-005

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 4 patient groups, including a placebo group

Squalamine Solution BID 0.2%

Experimental group

Description:

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

Treatment:

Drug: Squalamine Lactate Ophthalmic Solution 0.2%

Vehicle Solution 0.2% BID

Placebo Comparator group

Description:

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

Treatment:

Drug: Squalamine Lactate Ophthalmic Solution 0.2%

Squalamine Solution 0.2% QID

Experimental group

Description:

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

Treatment:

Drug: Squalamine Lactate Ophthalmic Solution 0.2%

Vehicle Solution 0.2% QID

Placebo Comparator group

Description:

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

Treatment:

Drug: Squalamine Lactate Ophthalmic Solution 0.2%