NCT01402544

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2011

Typical duration for phase_2

Geographic Reach
1 country

4 active sites

Status
terminated

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

July 1, 2011

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 26, 2011

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

August 28, 2019

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

3.7 years

First QC Date

July 25, 2011

Results QC Date

August 5, 2019

Last Update Submit

August 23, 2019

Conditions

Age-Related Macular Degeneration

Keywords

AMDChoroidal neovascularizationRanibizumabAge-related Macular DegenerationGenome

Outcome Measures

Primary Outcomes (1)

  • Number of Patients That Achieve Their Pre-wet Age-Related Macular Degeneration (AMD) Baseline Visual Acuity Within 12 Months

    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.

    Baseline, Month 6 and Month 12

Secondary Outcomes (2)

  • Mean Change in Best Corrected Visual Acuity (BCVA) From Baseline to 6 Months and Baseline to 12 Months.

    Baseline, Month 6 and Month 12

  • Mean Change in Central Foveal Thickness (CFT) From Baseline to 6 Months and Baseline to 12 Months

    Baseline, Month 6 and Month 12

Study Arms (1)

Ranibizumab 0.5 mg

OTHER

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

Drug: ranibizumab

Interventions

ranibizumabDRUG

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

Also known as: Lucentis
Ranibizumab 0.5 mg

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 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

California Retina Consultants

Bakersfield, California, 93309, United States

Location

Shiley Eye Center, UCSD

La Jolla, California, 92093, United States

Location

California Retina Consultants

Santa Barbara, California, 93103, United States

Location

Medical Center Ophthalmology Associates

San Antonio, Texas, 78240, United States

Location

MeSH Terms

Conditions

Macular DegenerationChoroidal Neovascularization

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesChoroid DiseasesUveal DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Dr. Henry Ferreyra
Organization
Univeristy of California, San Diego
hferreyra@ucsd.edu
858-822-7982

Study Officials

  • Henry Ferreyra, MD

    University of California, San Diego

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

July 25, 2011

First Posted

July 26, 2011

Study Start

July 1, 2011

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

August 28, 2019

Results First Posted

August 28, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(4)