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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Neovascular Age-related Macular Degeneration

Intervention / Treatment
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* Drug: Ranibizumab (Lucentis)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ranibizumab (Lucentis)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in visual acuity vs baseline |  |  | 
| Change in OCT central retinal thickness vs baseline |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neovascularization, Age-related macular degeneration, Ranibizumab (Lucentis), Optical coherence tomography, Intravitreal injection