Study of Efficacy of Ranibizumab in Different Regimens in Patients With Diabetic Macula Edema (DIVERSE)

Novartis

Status and phase: Completed; Phase 4

Conditions: Diabetic Retinopathy

Treatments: Drug: ranibizumab 0.5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02366468

2014-002854-37 (EudraCT Number)

CRFB002DDE26

Details and patient eligibility

About

The purpose of this study was to demonstrate that the change of best corrected visual acuity (BCVA) was comparable in patients treated with ranibizumab at the discretion of the investigator vs. treatment according to a standard of care scheme (pro re nata, as needed).

Enrollment: 135 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) ≤ 12.0%
• Patients with visual impairment due to DME in at least one eye
• BCVA ≥ 24 and ≤ 78 letters in the study eye

Exclusion criteria

• Active intraocular inflammation
• Any active infection in either eye at the
• Structural damage within 0.5 disc diameter of the center of the macula in the study eye
• Uncontrolled glaucoma in either eye at screening

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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135 participants in 2 patient groups

Discretion of the investigator (DI)

Experimental group

Description:

ranibizumab 0.5 mg, after initial monthly treatment until maximum BCVA and no signs or no further change of disease activity, the investigator treated patients at their own discretion. There were no strict recommendations for retreatment or scheduling of upcoming visits.

Treatment:

Drug: ranibizumab 0.5 mg

Pro re nata (PRN)

Active Comparator group

Description:

ranibizumab 0.5 mg, after initial monthly therapy until maximum BCVA and no signs or no further improvement of disease activity, patients were monitored every month and retreated if any signs of disease activity occurred

Treatment:

Drug: ranibizumab 0.5 mg