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

Neovascular Age-related Macular Degeneration Clinical Trial

Official title:

Prospective Optical Coherence Tomography (OCT) Imaging of Patients With Neovascular AMD Treated With Intra-Ocular Ranibizumab (Lucentis) (PrONTO) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00373659
• Other study ID #: IST-FVF3102
• Status: Completed
• Phase: Phase 2
• First received: September 7, 2006
• Last updated: June 12, 2012
• Start date: August 2004
• Est. completion date: June 2007

Study information

• Verified date: June 2012
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• Ranibizumab (Lucentis)

Locations

Country	Name	City	State
United States	Bascom Palmer Eye Instiyute	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in visual acuity vs baseline
Primary	Change in OCT central retinal thickness vs baseline
Secondary	Number of injections over 1 year
Secondary	Number of consecutive monthly injections until fluid-free
Secondary	Injection free interval
Secondary	Correlations of injection frequency with baseline lesion characteristics and visual acuity