Status:
COMPLETED
Prospective OCT Study With Lucentis for Neovascular AMD (PrONTO Study)
Lead Sponsor:
University of Miami
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Neovascular Age-Related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
The PrONTO Study was designed to evaluate the response of neovascular age-related macular degeneration (AMD) patients to intravitreal Lucentis using Optical Coherence Tomography (OCT) imaging. OCT was...
Detailed Description
This is a Phase II, open-label study of intravitreally administered ranibizumab (LucentisTM). Ranibizumab is an anti Vascular Endothelial Growth Factor (VEGF) antibody fragment. Approximately 40 subje...
Eligibility Criteria
Inclusion
- • All subjects must meet the following criteria to be eligible for study entry: Signed informed consent
- Age greater than 50 years
- Active primary or recurrent subfoveal lesions with CNV secondary to AMD in the study eye, as defined in Table 1
- Lesions with occult CNV or with some classic CNV component are permissible. However, if predominantly classic CNV (well-demarcated hyperfluorescence boundaries in the early phase of the fluorescein angiogram) is present, the patient must have had prior PDT (up to 3 previous photodynamic therapy treatments).
- The OCT features that will permit participation will include retinal thickness (macular edema) ≥300 microns, subretinal fluid ≥100 microns in thickness, or a detachment of the retinal pigment epithelium ≥100 microns in thickness
- The total area of CNV (including both classic and occult components) encompassed within the lesion must be ≥ 50% of the total lesion area
- The total lesion area must be \<12 disc areas (DA) in size.
- Best corrected visual acuity, using ETDRS charts, of 20/40 to 20/400 (Snellen equivalent) in the study eye
- Only one eye will be assessed in the study. If both eyes are eligible, the one with the better acuity will be selected for treatment and study unless, based on medical reasons, the investigator deems the other eye the more appropriate candidate for treatment and study.
Exclusion
- • Prior treatment with verteporfin, external-beam radiation therapy, or transpupillary thermotherapy in the study eye (predominantly classic CNV can however only be included if the subject had up to 3 prior PDT treatments)
- Treatment with verteporfin in the non-study eye less than 7 days preceding Day 0
- Previous participation in a clinical trial (for either eye) involving anti angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)
- Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye
- Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Day 0
- History of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye
- Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals) Lesion Characteristics
- Subfoveal fibrosis or atrophy in the study eye
- CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
April 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00344227
Start Date
August 1 2004
End Date
April 1 2007
Last Update
June 26 2006
Active Locations (1)
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1
Bascom Palmer Eye Institute
Miami, Florida, United States, 33136