Prospective OCT Study With Lucentis for Neovascular AMD (PrONTO Study)

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by:
University of Miami
ClinicalTrials.gov Identifier:
NCT00344227
First received: June 23, 2006
Last updated: NA
Last verified: June 2006
History: No changes posted
  Purpose

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 then used to determine the need for retreatment after 3 monthly injections of Lucentis. Patients would be followed for 2 years.


Condition Intervention Phase
Neovascular Age-Related Macular Degeneration
Drug: Lucentis (Ranibizumab)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Optical Coherence Tomography (OCT) Imaging of Patients With Neovascular Age-Related Macular Degeneration (AMD) Treated With Intra-Ocular Lucentis™ (Ranibizumab): PrONTO Study

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Mean Visual Acuity
  • Total number of treatments

Secondary Outcome Measures:
  • Time to decrease of OCT central retinal thickness
  • Time to improved visual acuity
  • Proportion gaining 3 lines of vision
  • Proportion stable or improved
  • Frequency of Retreatment

Estimated Enrollment: 40
Study Start Date: August 2004
Estimated Study Completion Date: April 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • 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 Criteria:

  • • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00344227

Locations
United States, Florida
Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Genentech, Inc.
Investigators
Principal Investigator: Philip J Rosenfeld, MD, PhD Bascom Palmer Eye Institute
  More Information

No publications provided by University of Miami

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00344227     History of Changes
Other Study ID Numbers: IST-FVF3102s, FVF3102s
Study First Received: June 23, 2006
Last Updated: June 23, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Miami:
neovascularization
age-related macular degeneration
vascular endothelial growth factor (VEGF)
antigen-binding fragment (Fab)
antiangiogenesis
optical coherence tomography (OCT)

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Eye Diseases
Retinal Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on October 23, 2014