Ranibizumab "Treat and Extend" in Diabetic Macular Edma

Novartis Pharmaceuticals7 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Macular Edema

Interventions

RanibizumabDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Novartis Investigative Site

Oslo, Norway

Outcomes

Primary Outcomes

Change in Best Corrected Visual Acuity(BCVA)

Time frame: from month 0 (baseline) to month 12

Secondary Outcomes

change in central retinal thickness (CRT)

Time frame: from month 0 to month 12

the number of injections needed

Time frame: 12 months

the number of patients with improvement in BCVA from baseline

Time frame: 12 months

the number of patients with > 5, 10 and 15 letters improvement from baseline, the latter including patients reaching BCVA >84

Time frame: 12 months

Data from ClinicalTrials.gov

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