Clinical Assessment Of Age-related Macular Degeneration Patients After Early Diagnosis and Treatment With Ranibizumab

Overview

To determine if patients treated early after diagnosis of wet age-related macular degeneration can return/maintain to their baseline pre-disease BCVA.

Full Title of Study: “Clinical Assessment Of Age-related Macular Degeneration Patients After Early Diagnosis and Treatment With Ranibizumab (COMPASS)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2015

Detailed Description

We will conduct an open label, multi-center study of naïve AMD patients that are identified early upon disease progression (had a normal VA, FA or OCT within 4 months prior to entry) to assess if treating with ranibizumab monthly can restore all patients to their baseline vision pre-AMD. Recent randomized clinical trials (MARINA, ANCHOR) have conclusively demonstrated that continued intravitreal therapy with ranibizumab in patients with subfoveal CNV from AMD leads to stabilization of vision in over 90% of patients and improvement in vision in at least a third of the patients and has led to the approval of ranibizumab (0.5 mg) for the treatment of neovascular AMD.

Patients will receive monthly intravitreal ranibizumab injections for 12 months (with dose holding for return to baseline/ 20/20 or better and no evidence of fluid on SD-OCT or FA). All patients will have ETDRS vision and SD-OCT, and complete exam at each monthly visit. Patients will each have a blood analysis for genetics (either during the GALLEY study in which they converted to wet AMD and entered COMPASS or during this study).

Interventions

  • Drug: ranibizumab
    • 0.5mg intravitreal injection, monthly for 12 months, or until BCVA returns to pre-wet AMD baseline.

Arms, Groups and Cohorts

  • Other: Ranibizumab 0.5 mg
    • Ranibizumab 0.5 mg Intravitreal Injection, monthly, open-label, for the duration of 1 year

Clinical Trial Outcome Measures

Primary Measures

  • Number of Patients That Achieve Their Pre-wet Age-Related Macular Degeneration (AMD) Baseline Visual Acuity Within 12 Months
    • Time Frame: Baseline, Month 6 and Month 12
    • PI is no longer affiliated with institution. All efforts were exhausted to obtain data from all sites for this study, but we only have access to data from UCSD site. Data from these participants is being reported here.

Secondary Measures

  • Mean Change in Best Corrected Visual Acuity (BCVA) From Baseline to 6 Months and Baseline to 12 Months.
    • Time Frame: Baseline, Month 6 and Month 12
    • Mean change was measured by letters gained or lost. A positive number is letters gained, and a negative number is letters lost.
  • Mean Change in Central Foveal Thickness (CFT) From Baseline to 6 Months and Baseline to 12 Months
    • Time Frame: Baseline, Month 6 and Month 12

Participating in This Clinical Trial

Inclusion Criteria

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age > 50 years
  • Naïve wet-AMD within 4 months of disease onset (for GALLEY patients) and within 3 months of disease onset for all others
  • Patients that have lost > 5 letters from baseline best vision
  • BCVA 20/25-20/320

Exclusion Criteria

  • Pregnancy (positive pregnancy test) or lactation
  • Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
  • Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
  • Participation in another simultaneous medical investigation or trial which includes an intervention (Patients could be participating in a non-interventional study such as the GALLEY study)
  • Juxtafoveal and extrafoveal wet-AMD

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of California, San Diego
  • Collaborator
    • Genentech, Inc.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Henry Ferreyra, Clinical Professor – University of California, San Diego
  • Overall Official(s)
    • Henry Ferreyra, MD, Study Chair, University of California, San Diego

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