Efficacy of Ranibizumab in Combination With Photodynamic Therapy for Wet Age-Related Macular Degeneration

McGill University

Status and phase: Unknown; Phase 4

Conditions: Macular Degeneration; Visual Acuity

Treatments: Drug: Ranibizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT00813891

MUHC - 1234 - RVH

Details and patient eligibility

About

The purpose of the investigators study is to look at the visual outcomes of Ranibizumab injections in combination with photodynamic therapy for the treatment of neovascular age-related macular degeneration.

Full description

The main cause of severe vision loss in patients with age-related macular degeneration (AMD) is the development of choroidal neovascularization (CNV). This debilitating form of AMD affects the macula lutea, the central part of the retina, which is responsible for high resolution visual acuity. Characteristic findings in neovascular AMD include the development of new, abnormal blood vessels in the choroid layer beneath the macula otherwise known as CNV.

Current treatment options for this condition have included include laser therapy, photodynamic therapy (PDT), and intraocular injections (different types of anti-vascular endothelial growth factors) alone or in combination. While current treatments were demonstrated to slow the progression of vision loss, neither therapy was shown to significantly improve visual acuity.

Given their different modes of action, it is believed that combination therapy of Ranibizumab with PDT may lead to better visual outcomes and may result in an improved effect in treating AMD and therefore may help decrease the need for monthly Ranibizumab injections. After the first injection, regardless of which group the patient has been assigned to, they will receive Ranibizumab injections at 4 week intervals if clinically indicated. The purpose of the this study is to evaluate the visual outcomes of intraocular Ranibizumab injections in combination with photodynamic therapy with verteporfin for the treatment of neovascular AMD.

Enrollment: 180 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosed with any subtype of primary subfoveal or juxtafoveal choroidal neovascularization
• must be 50 years of age or older
• have a lesion whose total size is no more than 5400micrometres in greatest linear dimension in the study eye
• CNV that is more than 50% obscured by blood
• have best corrected visual acuity of 20/50-20/320 (Snellen equivalent)
• have been assessed with the use of early treatment diabetic retinopathy study charts

Exclusion criteria

• previous treatment (including verteporfin therapy) that could compromise an assessment of the study treatment
• any permanent structural damage to the central fovea

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 3 patient groups

Pre-PDT

Active Comparator group

Description:

Participants in this group will receive an intraocular Ranibizumab injection one week prior to the first PDT with verteporfin.

Treatment:

Drug: Ranibizumab

Drug: Ranibizumab

Drug: Ranibizumab

Post-PDT

Active Comparator group

Description:

Participants in this group will receive an intraocular Ranibizumab injection one week post the first PDT with verteporfin.

Treatment:

Drug: Ranibizumab

Drug: Ranibizumab

Drug: Ranibizumab

No PDT

Active Comparator group

Description:

Participants in this group will receive an intraocular Ranibizumab injection with no accompanying PDT with verteporfin.

Treatment:

Drug: Ranibizumab

Drug: Ranibizumab

Drug: Ranibizumab