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Study EvAluating Genotypes While Using Lucentis 2 (SEAGUL2)

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Kang Zhang, MD, PhD, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01464723
First received: October 31, 2011
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of the study is to investigate whether the efficacy of Lucentis treatment for exudative age-related macular degeneration is associated with VEGF and HTRA1 DNA polymorphisms


Condition Intervention Phase
Age-Related Macular Degeneration
 Drug: Ranibizumab
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: VEGF and HTRA1 DNA Polymorphisms in Neovascular AMD Pathogenesis and Response to Lucentis

Resource links provided by NLM:

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

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • To determine the genotype at VEGF and HTRA1 SNPs of patients gaining ≥ 0 letters of visual acuity in response to ranibizumab treatment over a 4 month period. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the genotype at VEGF and HTRA1 SNPs of patients who lose visual acuity (gain <0 letters) at 4, 6 and 12 months after initial treatment. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • To determine whether change in retinal thickness is correlated with genotype [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • To determine the mean number of injections per year patients in the study require. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: May 2008
Study Completion Date: January 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lucentis
Consented, enrolled subjects will receive multiple open-label intravitreally administered 0.5 mg ranibizumab administered monthly for the first 4 months, and then as needed for a total duration of 12 months.
 Drug: Ranibizumab
Intravitreal injections of 0.5 mg ranibizumab administered monthly for the first 4 months, and then as needed for a total duration of 12 months.
Other Name: Lucentis

Detailed Description:

Age-related macular degeneration (AMD) is a progressive disease that causes irreversible visual impairment and blindness in nearly 50 million people globally. Although geographic atrophy and neovascularization represent the advanced forms of AMD, neovascular AMD is the more aggressive form and accounts for almost 90% of blindness from this disease. It is characterized by choroidal neovascularization (CNV) which is the development of abnormal blood vessels underneath the retina. Randomized clinical trials (MARINA, ANCHOR) have conclusively demonstrated that continued intravitreal therapy with Lucentis (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 Lucentis for the treatment of neovascular AMD (see investigator brochure). This study could provide insight as to the reasons that some patients do not experience vision stabilization with Lucentis, and could possibly help physicians to determine which patients are the best candidates for receiving Lucentis.

This is an open-label study of 100 treatment-naïve (study eye only) AMD patients treated on-label with intravitreally administered Lucentis. Consented, enrolled subjects will receive multiple open-label intravitreal injections of 0.5 mg ranibizumab administered monthly for the first 4 months, and then as needed for a total duration of 12 months. Their blood will be genotyped and sequenced for various SNPs on VEGF and HTRA1.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability to provide written informed consent and comply with the study assessments for the full duration of the study.
  • Age > 50 years.
  • Treatment naïve (study eye only) AMD patients that are determined to be candidates for ranbizumab.
  • Visual acuity 20/32 to 20/230.

Exclusion Criteria:

  • Pregnancy
  • Prior enrollment in the study
  • Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
  • Previous therapy in study eye for AMD or other retinal disease which may be used in the treatment of AMD.
  • Any other condition that the investigator believes would pose a significant hazard to the subject if on-label ranibizumab were prescribed
  • Any participation in another simultaneous medical investigation or trial for AMD *Concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy, advanced glaucoma)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01464723

Locations
United States, California
Shiley Eye Center, University of California, San Diego
San Diego, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
Genentech
Investigators
Principal Investigator: Kang Zhang, MD, PhD UCSD, Shiley Eye Center
  More Information

No publications provided

Responsible Party: Kang Zhang, MD, PhD, Principal Investigator, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01464723     History of Changes
Other Study ID Numbers: 080693
Study First Received: October 31, 2011
Last Updated: January 22, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013