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

NCT00373659 | Completed Phase 2

• 1 other identifier: IST-FVF3102
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Neovascular Age-related Macular Degeneration

Keywords

Neovascularization; Age-related macular degeneration; Ranibizumab (Lucentis); Optical coherence tomography; Intravitreal injection

Outcome Measures

Primary Outcomes (2)

• Change in visual acuity vs baseline

• Change in OCT central retinal thickness vs baseline

Secondary Outcomes (4)

• 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

Interventions

Ranibizumab (Lucentis) DRUG

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

Bascom Palmer Eye Instiyute

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Neovascularization, Pathologic; Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Philip J Rosenfeld, MD PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Ophthalmology

Study Record Dates

• First Submitted: September 7, 2006
• First Posted: September 8, 2006
• Study Start: August 1, 2004
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: June 13, 2012

Record last verified: 2012-06

Locations

US (1)