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Retinal and Retinal Pigment Epithelium (RPE) Autoimmunity in Age-related Macular Degeneration (AMD) - Correlation With Lucentis(R) Therapy (Antibody)

This study is currently recruiting participants.
Verified August 2012 by University of California, Davis
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Lawrence S. Morse, MD, University of California, Davis
ClinicalTrials.gov Identifier:
NCT00931489
First received: June 29, 2009
Last updated: August 28, 2012
Last verified: August 2012
History of Changes
  Purpose

The investigators hope to determine if "wet" AMD patients differ from patients with "dry" AMD or normal eyes in the production of anti-retinal pigment epithelium (anti-RPE) or anti-retinal antibody formation. To explain: the immune system can make antibodies that attack our own cells, specifically the RPE and the retina. Normally the RPE and retinal cells are ignored by the immune system, but when disease occurs, immune reactions can occur, making an autoantibody that can attack the patient's own cells and make things worse. This production of autoantibodies that react with our own RPE and retinal cells is what the investigators want to test in this proposal to see if they may contribute to, or are responsible for, a poor response to treatment.

The investigators also want to know how those patients who initially respond to the standard-of-care treatment, ranibizumab injections, differ in the production of anti-RPE or anti-retinal antibody formation, from those patients who do not respond initially after 4 consecutive injections.


Condition Intervention Phase
Age Related Macular Degeneration
 Drug: ranibizumab (Lucentis(R))
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Retinal and RPE Autoimmunity in AMD: Assessment of Correlation With Degree of Response to Ranibizumab Therapy

Resource links provided by NLM:

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

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • To determine if "wet" AMD patients (Group 1 and Group 3) differ from population normals (Group 2) in the production of anti-Retinal Pigment Epithelium (RPE) or anti-retinal antibody formation. [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine mean change in visual acuity (VA) and ocular coherence tomography (OCCT) from baseline to month 6 [ Time Frame: One Year ] [ Designated as safety issue: No ]

Estimated Enrollment: 131
Study Start Date: August 2009
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Wet AMD Patients Responders
Dilated eye exam once a month for 7 months; visual acuity and OCT once a month for 7 months; Lucentis(R)/ranibizumab injection once each month for the Baseline and Month 1-3 visits, then as needed at Month 4 and 5; 3 Tbls. blood draw at Baseline, Month 3 and Month 6 visits.
 Drug: ranibizumab (Lucentis(R))
0.5 mg intravitreal injection once a month for 4 months, then as needed for 2 months
Other Name: Lucentis(R)
No Intervention: Normal Population
Dilated eye exam and 3 Tbls. blood draw at first and only study visit.
Active Comparator: Wet AMD Patients Non-responders
Participants in this Group will have not responded to 4 prior injections of Lucentis(R)/ranibizumab. Dilated eye exam at Month 4; visual acuity and OCT at Months 4-6; injection of Lucentis(R) as need at Months 4 and 5; 3 Tbls. blood draw at Month 4
 Drug: ranibizumab (Lucentis(R))
0.5 mg intravitreal injection once a month for 4 months, then as needed for 2 months
Other Name: Lucentis(R)
No Intervention: Dry AMD Population
Dilated eye exam and 3 Tbls. blood draw at first and only study visit.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Group 1 (Ranibizumab Responders):

    • Ability to provide written informed consent and comply with study assessments for the full duration of the study
    • Age > 50 years
    • Patients with active neovascular "wet" AMD naïve to treatment

  • Group 2 (Normal Controls):

    • Age-sex-race matched to Group 1 patients
    • Non-AMD
    • Ability to provide written informed consent

  • Group 3 (Anti-VEGF Initial Non-responders):

    • "Wet" AMD patient treated with 4 or more monthly injections of anti-VEGF treatment without an adequate response (persistent fluid on OCT)
    • Ability to provide written informed consent and comply with study assessments for the full duration of the study
    • Age > 50 years

  • Group 4 ("Dry" AMD):

    • Age-sex-race matched to Group 1 patients
    • "Dry" AMD, category 2 or 3 by AREDS (Age-Related Eye Disease Study) criteria
    • Ability to provide written informed consent

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
  • Concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy, advanced glaucoma)
  • Previous AMD therapy
  • Patients being treated for autoimmune or other disease with immunomodulatory drugs (i.e., prednisone, infliximab, methotrexate)
  • Patients with recent (less than 6 months) ocular or systemic surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00931489

Contacts
Contact: Lawrence S Morse, MD, PhD 916-734-6074 lsmorse@ucdavis.edu
Contact: Ember Dhillon, BA 916-734-6422 ember.dhillon@ucdmc.ucdavis.edu

Locations
United States, California
University of California, Davis Recruiting
Sacramento, California, United States, 95817
Sponsors and Collaborators
Lawrence S. Morse, MD
Genentech
Investigators
Principal Investigator: Lawrence S Morse, MD, PhD University of California, Davis
  More Information

No publications provided

Responsible Party: Lawrence S. Morse, MD, Professor, University of California, Davis
ClinicalTrials.gov Identifier: NCT00931489     History of Changes
Other Study ID Numbers: 217330, FVF4479s
Study First Received: June 29, 2009
Last Updated: August 28, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Davis:
Age Related Macular Degeneration
Lucentis
Ranibizumab
Antibodies
Retinal and RPE Autoimmunity

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

ClinicalTrials.gov processed this record on May 22, 2013