Clinical trial NCT00373659: An OCT-Guided Variable Dosing Regimen With Ranibizumab for the Treatment of Neovascular AMD
Official title: Prospective Optical Coherence Tomography (OCT) Imaging of Patients With Neovascular AMD Treated With Intra-Ocular Ranibizumab (Lucentis) (PrONTO) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neovascular Age-related Macular Degeneration
Keywords: Neovascularization
Age-related macular degeneration
Ranibizumab (Lucentis)
Optical coherence tomography
Intravitreal injection
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2006-09-08
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in visual acuity vs baseline
measure: Change in OCT central retinal thickness vs baseline
Secondary outcomes:
measure: Number of injections over 1 year
measure: Number of consecutive monthly injections until fluid-free
measure: Injection free interval
measure: Correlations of injection frequency with baseline lesion characteristics and visual acuity
Other outcomes:
Locations:
city: Miami
country: United States
facility: Bascom Palmer Eye Instiyute
state: Florida
Study officials:
affiliation: University of Miami
name: Philip J Rosenfeld, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: