NCT00500344

Brief Summary

CNV from AMD is the leading cause of blindness in people over 50 in North America. The hypothesis is to determine if there is an improvement in retinal function determined by ERG following treatment with ranibizumab for AMD

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2007

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

July 1, 2007

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 12, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

May 3, 2018

Status Verified

April 1, 2018

Enrollment Period

1.7 years

First QC Date

July 10, 2007

Last Update Submit

April 30, 2018

Conditions

Age-related Macular Degeneration

Keywords

Age-related Macular DegenerationChoroidal NeovascularizationElectroretinographyRetinal Function

Outcome Measures

Primary Outcomes (1)

  • To determine if there is an improvement in retinal function determined by the ERG following treatment with ranibizumab

    6 months

Secondary Outcomes (3)

  • To determine if there is an improvement in visual acuity and retinal function as determined by ERG

    6 months

  • Correlation between change in PERG and mean change in VA at 6 months

    6 months

  • Mean change in VA from baseline to 0 months and 6 months

    6 months

Study Arms (1)

1

OTHER
Drug: Lucentis (ranibizumab)

Interventions

Lucentis (ranibizumab)DRUG

intravitreal injection

1

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
  • Treatment naive AMD patients that are determined to be candidates for ranibizumab
  • Visual acuity 20/40 to 20/320

You may not qualify if:

  • Pregnancy
  • Prior enrollment in the study
  • Previous therapy for AMD or other retinal diseases 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 condition that would interfere with the ERG recording (such as media opacities including lens or corneal opacity)
  • Concurrent eye disease in the study eye that could compromise visual acuity (such as diabetic retinopathy, advanced glaucoma)
  • Any condition causing the patient to have a significant tremor that would interfere with the patient's ability to remain still during the ERG (such as Parkinson's disease)
  • Participation in another simultaneous medical investigation or trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

Related Publications (3)

  • Klein R, Peto T, Bird A, Vannewkirk MR. The epidemiology of age-related macular degeneration. Am J Ophthalmol. 2004 Mar;137(3):486-95. doi: 10.1016/j.ajo.2003.11.069.

    PMID: 15013873BACKGROUND

  • van Leeuwen R, Klaver CC, Vingerling JR, Hofman A, de Jong PT. Epidemiology of age-related maculopathy: a review. Eur J Epidemiol. 2003;18(9):845-54. doi: 10.1023/a:1025643303914.

    PMID: 14561043BACKGROUND

  • Sheybani A, Brantley MA Jr, Apte RS. Pattern electroretinography in age-related macular degeneration. Arch Ophthalmol. 2011 May;129(5):580-4. doi: 10.1001/archophthalmol.2011.83.

    PMID: 21555610DERIVED

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

Study Officials

  • Rajendra S. Apte, MD, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Rajendra S. Apte MD, PHD

Study Record Dates

First Submitted

July 10, 2007

First Posted

July 12, 2007

Study Start

July 1, 2007

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

May 3, 2018

Record last verified: 2018-04

Locations

US(1)