Ranibizumab "Treat and Extend" in Diabetic Macular Edma (OPTIMAL)

Novartis

Status and phase: Completed; Phase 4

Conditions: Diabetic Macular Edema

Treatments: Drug: Ranibizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01297569

CRFB002DNO02

2010-021182-76 (EudraCT Number)

Details and patient eligibility

About

This study is designed to explore a more individualized treatment regime based on achievement of disease stability to define a personal optimal treatment interval with ranibizumab in patients with visual impairment due to diabetic macular edema.

Enrollment: 7 patients

Sex: All

Ages: 18 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Visual impairment due to focal or diffuse macular edema with center involvement
• Diabetes type 1 or 2, HbA1c < 12.0%
• CRT = or > 250 μm

Exclusion criteria

• Active inflammation or infection
• Uncontrolled glaucoma
• Iris neovascularization, active proliferative retinopathy or vitreomacular traction
• Prior laser photocoagulation according to defined timelines
• History of stroke, uncontrolled hypertension

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Ranibizumab

Experimental group

Treatment:

Drug: Ranibizumab