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

Phase 1

Completed

• Conditions: Macular Degeneration
• Interventions: Drug: Lucentis; Drug: Ranibizumab; Drug: Ranibizumab (Lucentis)

• Registration Number: NCT00395707
• Lead Sponsor: The National Retina Institute

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2006-11-01
• Study First Submitted QC: 2006-11-01
• Study First Posted: 2006-11-03
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-06
• Last Update Posted: 2009-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Lucentis	Lucentis 0.5mg/0.05 ml
1	Ranibizumab	Lucentis 0.3mg/0.05 ml
1	Ranibizumab (Lucentis)	Lucentis 0.3mg/0.05 ml
1	Lucentis	Lucentis 0.3mg/0.05 ml
2	Ranibizumab (Lucentis)	Lucentis 0.5mg/0.05 ml
2	Ranibizumab	Lucentis 0.5mg/0.05 ml

Primary Outcome Measures

Name	Time	Method
Proportion of patients with stabilization of visual acuity, vision loss of < 15 letters	2 years
Proportion of subjects who gain at least 15 letters in the best corrected visual acuity score at 6 and 12 months compared to baseline	12 months
Incidence and severity of ocular adverse events	12 months
Incidence and severity of non-ocular adverse events	12 months
Changes in vital signs	12 months

Secondary Outcome Measures

Name	Time	Method
Assess the systemic and local safety of ranibizumab (0.3mg or 0.5mg) in patients with RAP lesions	12 months
Assess the impact of ranibizumab (0.3mg or 0.5mg) on time to improvement in retinal thickness by OCT	2 years
Assess the impact of ranibizumab (0.3mg or 0.5mg) on development of retinal-choroidal anastomoses as determined on clinical examination and high speed ICG	2 years
Assess the impact of ranibizumab (0.3mg or 0.5 mg) on leakage from RAP lesions by Fluorescein angiography	2 years
Static / high speed ICG appearance to assess the impact of ranibizumab (0.3mg or 0.5mg) on persistence / recurrence of RAP lesion and monitor for development of retinal-choroidal anastomoses	2 years
Assess the impact of ranibizumab (0.3mg or 0.5mg) on development of subretinal fibrosis as determined by clinical examination	2 years

Trial Locations

Locations (1)

National Retina Institute; 🇺🇸 Towson, Maryland, United States