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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00373659
Recruitment Status : Completed
First Posted : September 8, 2006
Last Update Posted : June 13, 2012
Information provided by (Responsible Party):
Philip J. Rosenfeld, MD, PhD, University of Miami

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2004
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Primary Outcome Measures :
  1. Change in visual acuity vs baseline
  2. Change in OCT central retinal thickness vs baseline

Secondary Outcome Measures :
  1. Number of injections over 1 year
  2. Number of consecutive monthly injections until fluid-free
  3. Injection free interval
  4. Correlations of injection frequency with baseline lesion characteristics and visual acuity

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00373659

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

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Responsible Party: Philip J. Rosenfeld, MD, PhD, Professor of Ophthalmology, University of Miami Identifier: NCT00373659     History of Changes
Other Study ID Numbers: IST-FVF3102
First Posted: September 8, 2006    Key Record Dates
Last Update Posted: June 13, 2012
Last Verified: June 2012
Keywords provided by Philip J. Rosenfeld, MD, PhD, University of Miami:
Age-related macular degeneration
Ranibizumab (Lucentis)
Optical coherence tomography
Intravitreal injection
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents