Topical Application of Latanoprost in Diabetic Retinopathy (Latano-2)

University of Aarhus

Status and phase: Completed; Phase 4

Conditions: Diabetic Retinopathy

Treatments: Drug: Latanoprost

Study type: Interventional

Funder types: Other

Identifiers

NCT01225653

2010-022433-29 (EudraCT Number)

Latano-2

Details and patient eligibility

About

Randomized double-blinded two-year intervention study with topical application of latanoprost or placebo eye drops in patients with diabetic retinopathy.

Full description

The primary objective is to study if a sustained contraction of pathologically dilated retinal arterioles can be obtained. Retinal arteriolar diameter and the diameter response to increased blood pressure is studied using the Dynamic Vessel Analyzer (Imedos, Germany.

The secondary objective is to study whether the intervention can halt the development of diabetic retinopathy, which is assessed by optical coherence tomography (OCT) scanning and fundus photography.

Enrollment: 27 patients

Sex: All

Ages: 20 to 36 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 20-36 years old
• Diabetes mellitus with retinopathy

Exclusion criteria

• Pregnancy
• Previous ocular disease other than diabetic retinopathy
• General disease with possible influence on the eye

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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27 participants in 2 patient groups, including a placebo group

Latanoprost

Experimental group

Description:

Topical treatment with latanoprost

Treatment:

Drug: Latanoprost

Placebo

Placebo Comparator group

Description:

Placebo arm

Treatment:

Drug: Latanoprost