Efficacy of Aliskiren in the Treatment of Diabetic Macular Edema

Novartis

Status and phase: Terminated; Phase 2

Conditions: Diabetic Macular Edema

Treatments: Drug: Placebo; Drug: Aliskiren

Study type: Interventional

Funder types: Industry

Identifiers

NCT00768040

EudraCT 2008-00581-23

CSPP100A2244

Details and patient eligibility

About

To assess the efficacy of oral aliskiren as a therapy for diabetic macular edema

Enrollment: 39 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 or type 2 diabetes
• Diabetic macular edema

Exclusion criteria

• Recent intra-ocular surgery in the study eye (e.g., cataract surgery in the last 6 months)
• Recent laser photocoagulation in the study eye
• Recent treatment with Avastin, Lucentis, or intravitreal corticosteroids in the study eye

Other protocol-defined inclusion/exclusion criteria applied

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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39 participants in 2 patient groups, including a placebo group

Aliskiren 300 mg

Experimental group

Description:

Aliskiren 300 mg once daily for 12 weeks

Treatment:

Drug: Aliskiren

Placebo

Placebo Comparator group

Description:

Matching placebo once daily for 12 weeks

Treatment:

Drug: Placebo