Verteporfin Photodynamic Therapy Administered in Conjunction With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration (AMD)

Novartis

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Choroidal Neovascularization; Macular Degeneration

Treatments: Drug: Placebo; Drug: Verteporfin Photodynamic Therapy; Drug: Ranibizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00433017

CBPD952A2309

Details and patient eligibility

About

This study will evaluate the effect of combination therapy with verteporfin photodynamic therapy and ranibizumab on visual acuity compared to ranibizumab monotherapy and the durability of response observed in patients with choroidal neovascularization secondary to age-related macular degeneration

Enrollment: 255 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects of either gender age 50 years or older
• Subfoveal choriodal neovascularization (CNV) due to age-related macular degeneration (AMD)

Exclusion criteria

• Choriodal neovascularization due to causes other than AMD
• Prior treatment for neovascular AMD in the study eye

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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255 participants in 2 patient groups

Verteporfin + Ranibizumab

Experimental group

Description:

Verteporfin (6 mg/m\^2) photodynamic therapy (PDT) and ranibizumab (0.5 mg). Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).

Treatment:

Drug: Ranibizumab

Drug: Verteporfin Photodynamic Therapy

Ranibizumab Monotherapy

Active Comparator group

Description:

Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).

Treatment:

Drug: Ranibizumab

Drug: Placebo