Efficacy and Safety of Lucentis® Use in Patients With Diabetic Macular Edema Evaluating a Spaced Out Follow-up After Intensive Treatment Phase (CONSTELLATION)

Novartis

Status and phase: Terminated; Phase 3

Conditions: Diabetes; Macular Degeneration; Macular Edema

Treatments: Drug: Ranibizumab 0.5mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02032173

CRFB002DFR11

Details and patient eligibility

About

The study was designed to assess the efficacy and safety of Lucentis® (ranibizumab 0.5 mg) in diabetic patients presenting with reduced visual acuity due to diabetic macular edema and evaluating spacing out of follow-up after initial intensive treatment phase.

Full description

This was a multicenteric, open-label, phase IIIb study, which comprised of 2 groups: the Main Group and the Rescue Group.

Patient's eligibility was assessed during a screening visit (Visit 1) which took place 14 days maximum before treatment initiation (Visit 2 [Day 0]). All patients were initially included in the Main Group and were to receive an initial loading treatment (6 injections during the intensive treatment phase i.e. every month from Day 0 to Month 5, followed by 2 additional injections at Months 8 and 11). Patients were to be followed-up every 3 months for 18 months (spaced-out follow-up period). Their visual acuity was to be checked at each study visit (Months 3, 6, 8, 11, 14, 17, 20, and 23) to assess their response to treatment. Patients who responded to treatment were maintained in the Main Group. Patients who did not meet pre defined criteria were moved to the Rescue Group and treated at the investigator's discretion.

The trial was terminated before any patient reached month 12.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type I or type II diabetes with HbA1c≤10%
• Visual impairment due to a diabetic macular edema
• Stable antidiabetic treatment (since more than 3 months) or hygiene-dietary

Exclusion criteria

• Inflammation or infection in one eye
• Women of childbearing potential without an efficient contraception, pregnant or breastfeeding

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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31 participants in 1 patient group

Ranibizumab 0.5mg

Experimental group

Description:

Intravitreal injection with standard dose of 0.5 mg/0.05mL Pro re nata (PRN)

Treatment:

Drug: Ranibizumab 0.5mg