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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Philip J. Rosenfeld, MD, PhD, University of Miami
ClinicalTrials.gov Identifier:
NCT00373659
First received: September 7, 2006
Last updated: June 12, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


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

Study Type: Interventional
Study Design: 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 AMD Treated With Intra-Ocular Ranibizumab (Lucentis) (PrONTO) Study

Resource links provided by NLM:

Drug Information available for: Ranibizumab
U.S. FDA Resources

Further study details as provided by University of Miami:

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

Enrollment: 40
Study Start Date: August 2004
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00373659

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

No publications provided

Responsible Party: Philip J. Rosenfeld, MD, PhD, Professor of Ophthalmology, University of Miami
ClinicalTrials.gov Identifier: NCT00373659     History of Changes
Other Study ID Numbers: IST-FVF3102
Study First Received: September 7, 2006
Last Updated: June 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Miami:
Neovascularization
Age-related macular degeneration
Ranibizumab (Lucentis)
Optical coherence tomography
Intravitreal injection

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

ClinicalTrials.gov processed this record on May 19, 2013