Back to resultsAn OCT-Guided Variable Dosing Regimen With Ranibizumab for the Treatment of Neovascular AMD
Primary Purpose
Neovascular Age-related Macular Degeneration
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ranibizumab (Lucentis)
Sponsored by
About this trial
This is an interventional treatment trial for Neovascular Age-related Macular Degeneration focused on measuring Neovascularization, Age-related macular degeneration, Ranibizumab (Lucentis), Optical coherence tomography, Intravitreal injection
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
Sites / Locations
- Bascom Palmer Eye Instiyute
Outcomes
Primary Outcome Measures
Change in visual acuity vs baseline
Change in OCT central retinal thickness vs baseline
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00373659
Brief Title
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
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Age-related Macular Degeneration
Keywords
Neovascularization, Age-related macular degeneration, Ranibizumab (Lucentis), Optical coherence tomography, Intravitreal injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ranibizumab (Lucentis)
Primary Outcome Measure Information:
Title
Change in visual acuity vs baseline
Title
Change in OCT central retinal thickness vs baseline
Secondary Outcome Measure Information:
Title
Number of injections over 1 year
Title
Number of consecutive monthly injections until fluid-free
Title
Injection free interval
Title
Correlations of injection frequency with baseline lesion characteristics and visual acuity
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip J Rosenfeld, MD PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bascom Palmer Eye Instiyute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Learn more about this trial
An OCT-Guided Variable Dosing Regimen With Ranibizumab for the Treatment of Neovascular AMD
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