NCT00467935

Brief Summary

This is a trial aimed at patients with advanced wet macular degeneration and macular scarring treated wiht intravitreal injections of Lucentis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2007

Shorter than P25 for phase_1

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

March 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

July 29, 2011

Status Verified

July 1, 2011

Enrollment Period

8 months

First QC Date

April 29, 2007

Last Update Submit

July 28, 2011

Conditions

Macular Degeneration

Keywords

amddisciformfibrosisLucentisscotoma

Outcome Measures

Primary Outcomes (1)

  • scotoma reduction

    12 months

Secondary Outcomes (1)

  • improved visual function

    12 months

Interventions

intravitreal injection Lucentis (ranibizumab)DRUG

intravitreal injection Lucentis (ranibizumab)

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BCVA \< 20/320
  • Disciform macular degeneration wiht exudation

You may not qualify if:

  • Non-amd CNV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Retina Research Center

Slingerlands, New York, 12159, United States

Location

Related Links

MeSH Terms

Conditions

Macular DegenerationGlycogen Storage Disease Type IIFibrosisScotoma

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesLysosomal Storage Diseases, Nervous SystemBrain Diseases, Metabolic, InbornBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGlycogen Storage DiseaseCarbohydrate Metabolism, Inborn ErrorsLysosomal Storage DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVision DisordersSensation DisordersNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Paul M Beer, MD

    Retina Research Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 29, 2007

First Posted

May 1, 2007

Study Start

March 1, 2007

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

July 29, 2011

Record last verified: 2011-07

Locations

US(1)