Assess the Efficacy/Safety of Intravitreal Ranibizumab in Patients With Vision Loss Due to Choroidal Neovascularization.

Novartis

Status and phase: Completed; Phase 3

Conditions: Choroidal Neovascularization (CNV)

Treatments: Drug: Ranibizumab; Other: Sham control

Study type: Interventional

Funder types: Industry

Identifiers

NCT01840410

CRFB002G2301

2012-005417-38 (EudraCT Number)

Details and patient eligibility

About

This study was conducted to evaluate the efficacy and safety of 0.5 mg ranibizumab in adult and adolescent patients with visual impairment due to choridal neovascularization (CNV).

Enrollment: 183 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Diagnosis of active CNV secondary to any causes with the CNV or its sequelae affecting the fovea;
• BCVA must be between ≥ 24 and ≤ 83 letters in the study eye;
• Visual loss in the study eye should mainly be due to the presence of any eligible types of CNV;

Key Exclusion Criteria:

• Women of child-bearing potential;
• Active malignancies;
• History of stroke less than 6 months prior to screening;
• Uncontrolled systemic inflammation or infection;
• Active diabetic retinopathy, active ocular/periocular infectious disease or active severe intra-ocular inflammation;
• CNV- conditions with a high likelihood of spontaneous resolution;
• History of intravitreal treatment with steroids;
• History of laser photocoagulation;
• History of intraocular treatment with any anti-angiogenic drugs.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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183 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 could switch to open-label ranibizumab on an as needed basis.

Treatment:

Other: Sham control