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

University of Miami

Status and phase

Completed

Phase 2

Conditions

Neovascular Age-related Macular Degeneration

Treatments

Drug: Ranibizumab (Lucentis)

Study type

Interventional

Funder types

Other

Identifiers

NCT00373659

IST-FVF3102

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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