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Study EvAluating Genotypes While Using Lucentis 2 (SEAGUL2)

Primary Purpose

Age-Related Macular Degeneration

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ranibizumab
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-Related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Shiley Eye Center, University of California, San Diego

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lucentis

Arm Description

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.

Outcomes

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.

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.
To Determine Whether Change in Retinal Thickness is Correlated With Genotype
To Determine the Mean Number of Injections Per Year Patients in the Study Require.

Full Information

First Posted
October 31, 2011
Last Updated
July 25, 2019
Sponsor
University of California, San Diego
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01464723
Brief Title
Study EvAluating Genotypes While Using Lucentis 2
Acronym
SEAGUL2
Official Title
VEGF and HTRA1 DNA Polymorphisms in Neovascular AMD Pathogenesis and Response to Lucentis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Diego
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lucentis
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
To Determine Whether Change in Retinal Thickness is Correlated With Genotype
Time Frame
5 years
Title
To Determine the Mean Number of Injections Per Year Patients in the Study Require.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
Shiley Eye Center, University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data not available for sharing.
Citations:
PubMed Identifier
23745581
Citation
Zhao L, Grob S, Avery R, Kimura A, Pieramici D, Lee J, Rabena M, Ortiz S, Quach J, Cao G, Luo H, Zhang M, Pei M, Song Y, Tornambe P, Goldbaum M, Ferreyra H, Kozak I, Zhang K. Common variant in VEGFA and response to anti-VEGF therapy for neovascular age-related macular degeneration. Curr Mol Med. 2013 Jul;13(6):929-34. doi: 10.2174/15665240113139990048.
Results Reference
derived

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Study EvAluating Genotypes While Using Lucentis 2

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