NCT01464723

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 3, 2011

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
6.6 years until next milestone

Results Posted

Study results publicly available

August 14, 2019

Completed
Last Updated

August 14, 2019

Status Verified

July 1, 2019

Enrollment Period

3.6 years

First QC Date

October 31, 2011

Results QC Date

July 25, 2019

Last Update Submit

July 25, 2019

Conditions

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • 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.

    5 years

Secondary Outcomes (3)

  • 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.

    5 years

  • To Determine Whether Change in Retinal Thickness is Correlated With Genotype

    5 years

  • To Determine the Mean Number of Injections Per Year Patients in the Study Require.

    5 years

Study Arms (1)

Lucentis

EXPERIMENTAL

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

Interventions

RanibizumabDRUG

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.

Also known as: Lucentis
Lucentis

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shiley Eye Center, University of California, San Diego

San Diego, California, 92093, United States

Location

Related Publications (1)

  • 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.

    PMID: 23745581DERIVED

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Limitations and Caveats

The PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful due to all study team members having left. No study data are available, attempts were made to find the data but were unsuccessful.

Results Point of Contact

Title
Dr. Stuart Brown
Organization
University of California San Diego Shiley Eye Center
sibrown@ucsd.edu
(858) 822-2585858-246-0814

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2011

First Posted

November 3, 2011

Study Start

May 1, 2008

Primary Completion

December 1, 2011

Study Completion

January 1, 2013

Last Updated

August 14, 2019

Results First Posted

August 14, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Data not available for sharing.

Locations

US(1)