To Assess the Efficacy and Safety of Intravitreal Ranibizumab in People With Vision Loss Due to Macular Edema

Novartis

Status and phase: Completed; Phase 3

Conditions: Macular Edema (ME)

Treatments: Drug: Ranibizumab; Other: Sham control

Study type: Interventional

Funder types: Industry

Identifiers

NCT01846299

2012-005418-20 (EudraCT Number)

CRFB002G2302

Details and patient eligibility

About

To evaluate the efficacy and safety of 0.5 mg Ranibizumab intravitreal injections in adult patients with visual impairment due to macular edema (ME).

Enrollment: 181 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of active ME secondary to any causes (for adult patients: except diabetic macular edema (DME), age-related macular degeneration (AMD) and retinal vein occlusion (RVO));
• BCVA must be between ≥ 24 and ≤ 83 letters;
• Visual loss should be mainly due to the presence of any eligible types of ME.

Exclusion criteria

• Women of child-bearing potential,
• Active malignancies;
• History of stroke less than 6 months prior to screening;
• Uncontrolled systemic inflammation or infection, related directly to the underlying causal disease of ME;
• Active diabetic retinopathy, active ocular/periocular infectious disease or active severe intra-ocular inflammation;
• Any type of advanced, severe or unstable ocular disease or its reatment;
• ME with a high likelihood of spontaneous resolution.

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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181 participants in 2 patient groups

Ranibizumab

Experimental group

Description:

A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.

Treatment:

Drug: Ranibizumab

Sham control

Sham Comparator group

Description:

Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At month 1, if treatment was needed, sham was administered. At month 2, participants switched to open-label ranibizumab on an as needed basis.

Treatment:

Other: Sham control