An OCT-Guided Variable Dosing Regimen With Ranibizumab for the Treatment of Neovascular AMD

Phase 2

Completed

• Conditions: Neovascular Age-related Macular Degeneration

• Registration Number: NCT00373659
• Lead Sponsor: University of Miami

Brief Summary

This study was designed to evaluate a variable dosing regimen with intravitreal ranibizumab for the treatment of patients with neovascular age-related macular degeneration (AMD) in the Prospective OCT Imaging of Patients with Neovascular AMD Treated with Intra-Ocular Ranibizumab (PrONTO) study.

Detailed Description

In this 2-year open-label, prospective, single-center, uncontrolled, investigator sponsored clinical study, neovascular AMD patients with subfoveal CNV (N=40) and a central retinal thickness of at least 300 µm as measured by optical coherence tomography (OCT) were enrolled to receive 3 consecutive monthly intravitreal injections of ranibizumab (0.5 mg). Thereafter, retreatment with ranibizumab was performed if one of the following changes were observed between visits: a loss of 5 letters in conjunction with fluid in the macula as detected by OCT, an increase in OCT central retinal thickness of at least 100 μm, new onset classic CNV, new macular hemorrhage, or persistent macular fluid following an injection of ranibizumab at the prior study visit.

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2006-09-07
• Study First Submitted QC: 2006-09-07
• Study First Posted: 2006-09-08
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-12
• Last Update Posted: 2012-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age 50 years or older
• Active primary or recurrent macular neovascularization secondary to age-related macular degeneration (AMD) involving the central fovea in the study eye with evidence of disease progression
• OCT central retinal thickness ≥ 300 microns
• Best corrected visual acuity, using ETDRS charts, of 20/40 to 20/400 (Snellen equivalent) in the study eye

Exclusion Criteria

• More than 3 prior treatments with verteporfin photodynamic therapy
• Previous participation in a clinical trial (for either eye) involving antiangiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors)
• Previous subfoveal focal laser photocoagulation in the study eye
• Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding day 0
• Subfoveal fibrosis or atrophy in the study eye
• History of vitrectomy surgery in the study eye
• Aphakia or absence of the posterior capsule in the study eye
• History of idiopathic or autoimmune-associated uveitis in either eye

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in visual acuity vs baseline
Change in OCT central retinal thickness vs baseline

Secondary Outcome Measures

Name	Time	Method
Number of injections over 1 year
Number of consecutive monthly injections until fluid-free
Injection free interval
Correlations of injection frequency with baseline lesion characteristics and visual acuity

Trial Locations

Locations (1)

Bascom Palmer Eye Instiyute; 🇺🇸 Miami, Florida, United States