Study To Determine Safety/Efficacy of Lucentis For Treatment Of Retinal Angiomatous Proliferation Secondary To Age Related Macular Degeneration

The National Retina Institute

Status and phase: Completed; Phase 2; Phase 1

Conditions: Macular Degeneration

Treatments: Drug: Ranibizumab; Drug: Lucentis; Drug: Ranibizumab (Lucentis)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00395707

FVF3423s

Details and patient eligibility

About

The primary objective of this study is to determine the safety & efficacy of ranibizumab for the treatment of retinal angiomatous proliferation secondary to age related macular degeneration.

Full description

This study will be a phase I/II open label interventional case series. Twenty patients with retinal angiomatous proliferation will be randomized to receive intravitreal ranibizumab at a dose of 0.3mg/0.05 ml or 0.5mg/0.05 ml. Patients will receive ranibizumab via a pars plana injection on a monthly basis for a total duration of therapy of 12 months. Patients will be followed for a complete 12-month treatment course.

Enrollment: 20 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Ability to provide written informed consent and comply with study assessments for the full duration of the study.
• Age > 50 years
• Definite characteristic signs of age related macular degeneration including drusen
• Presence of retinal angiomatous proliferation as determined by clinical signs (intra retinal hemorrhage, retinal edema, cystic retinal edema) and angiography (occult leakage on fluorescein angiography, hot spot on static ICG, visible RAP lesion of high speed ICG)

Exclusion criteria

• Prior treatment with verteporfin, external-beam radiation therapy, or transpupillary thermotherapy in the study eye (predominantly classic CNV can however only be included if the subject had up to 3 prior PDT treatments)
• Treatment with verteporfin in the non-study eye less than 7 days preceding Day 0
• Previous participation in a clinical trial (for either eye) involving anti angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)
• Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye
• Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Day 0
• History of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye
• Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

1

Active Comparator group

Description:

Lucentis 0.3mg/0.05 ml

Treatment:

Drug: Ranibizumab (Lucentis)

Drug: Ranibizumab (Lucentis)

Drug: Ranibizumab

Drug: Lucentis

2

Active Comparator group

Description:

Lucentis 0.5mg/0.05 ml

Treatment:

Drug: Ranibizumab (Lucentis)

Drug: Ranibizumab (Lucentis)

Drug: Ranibizumab

Drug: Lucentis