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

NCT00344227 | Completed Phase 2

• 2 other identifiers: IST-FVF3102sFVF3102s
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Neovascular Age-Related Macular Degeneration

Keywords

neovascularization; age-related macular degeneration; vascular endothelial growth factor (VEGF); antigen-binding fragment (Fab); antiangiogenesis; optical coherence tomography (OCT)

Outcome Measures

Primary Outcomes (2)

• Mean Visual Acuity

• Total number of treatments

Secondary Outcomes (5)

• 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

Interventions

Lucentis (Ranibizumab) DRUG

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

Related Publications (1)

• Lalwani GA, Rosenfeld PJ, Fung AE, Dubovy SR, Michels S, Feuer W, Davis JL, Flynn HW Jr, Esquiabro M. A variable-dosing regimen with intravitreal ranibizumab for neovascular age-related macular degeneration: year 2 of the PrONTO Study. Am J Ophthalmol. 2009 Jul;148(1):43-58.e1. doi: 10.1016/j.ajo.2009.01.024. Epub 2009 Apr 18.

  PMID: 19376495 DERIVED

MeSH Terms

Conditions

Neovascularization, Pathologic; Macular Degeneration; Fanconi Anemia, Complementation Group B

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Philip J Rosenfeld, MD, PhD

  Bascom Palmer Eye Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 23, 2006
• First Posted: June 26, 2006
• Study Start: August 1, 2004
• Study Completion: April 1, 2007
• Last Updated: June 26, 2006

Record last verified: 2006-06

Locations

US (1)