Efficacy and Safety of Ranibizumab in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia

Novartis

Status and phase: Completed; Phase 3

Conditions: Pathological Myopia

Treatments: Drug: Ranibizumab; Drug: Sham verteporfin PDT; Drug: Sham Ranibizumab; Drug: Verteporfin PDT

Study type: Interventional

Funder types: Industry

Identifiers

NCT01217944

CRFB002F2301

2010-021662-30 (EudraCT Number)

Details and patient eligibility

About

This study is designed to evaluate the efficacy and safety of two different dosing regimens of 0.5 mg ranibizumab given as intravitreal injection in comparison to verteporfin PDT in patients with visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia (PM).

Enrollment: 277 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Visual impairment due to choroidal neovascularization (CNV) secondary to PM
• Best corrected visual acuity (BCVA) in the study eye > 24 and < 78 Early Treatment Diabetic Retinopathy Study (ETDRS) letters
• High myopia (> -6D), anterior-posterior elongation > 26 mm; posterior changes compatible with the pathologic myopia
• Either lesion types in the study eye: subfoveal, juxtafoveal, extrafoveal

Exclusion criteria

• Patients with uncontrolled systemic or ocular diseases
• Blood pressure > 150/90 mmHg
• History of pan-retinal, focal/grid laser photocoagulation or intraocular treatment with any anti-VEGF or vPDT in the study eye
• Intravitreal treatment with corticosteroids or intraocular surgery within last 3 months in the study eye

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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277 participants in 3 patient groups

Ranibizumab driven by disease activity

Experimental group

Description:

Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria

Treatment:

Drug: Sham verteporfin PDT

Drug: Ranibizumab

Drug: Sham Ranibizumab

Ranibizumab driven by stabilization criteria

Experimental group

Description:

Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity

Treatment:

Drug: Sham verteporfin PDT

Drug: Ranibizumab

Drug: Sham Ranibizumab

Verteporfin PDT

Active Comparator group

Description:

Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.

Treatment:

Drug: Verteporfin PDT

Drug: Sham verteporfin PDT

Drug: Ranibizumab

Drug: Sham Ranibizumab