The Ranibizumab for Edema of the mAcula in Diabetes-2 (READ-2) Study

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Johns Hopkins University
Study ID
NCT00407381
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab — DRUG
    Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and pro re nata (PRN) with dosing criteria.
  • Laser photocoagulation — PROCEDURE
    Laser photocoagulation in either focal or grid pattern as determined by investigator.

Study Details

This study is being done to see if the investigational drug Ranibizumab (RBZ) given by injection into the eye, is safe and effective to use in people with diabetic macular edema (DME). The investigators want to compare RBZ to laser treatment which is the current standard way to treat DME. RBZ blocks a growth factor that is thought to be involved in the formation of abnormal blood vessels that cause loss of vision in patients with DME.

Key Dates

First listed
Dec 5, 2006
Start date
Dec 31, 2006
Status verified
Mar 2017
Primary completion
Aug 31, 2010
Completion
Aug 31, 2011

Study Design

Enrollment
126 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ranibizumab
    Ranibizumab (RBZ) intravitreal injection alone
  • Active Comparator: Laser
    Laser photocoagulation
  • Experimental: Laser with Ranibizumab
    Laser following intravitreal injection of RBZ

Primary Outcome Measure

Mean Change in Best Corrected Visual Acuity (BCVA) at Month 6 [ Time Frame: 6 months ]

Locations (20)

FacilityCityStateZIPSite coordinators
Retinal Consultants of ArizonaPhoenixArizona85014-
Retina-Vitreous Associates Medical GroupBeverly HillsCalifornia90211-
University of Southern CaliforniaLos AngelesCalifornia90033-
East Bay Retina ConsultantsOaklandCalifornia94609-
Retina Institute of CaliforniaPasadenaCalifornia91105-
University of California, San FranciscoSan FranciscoCalifornia94143-
Yale Eye CenterNew HavenConnecticut06511-
Emory UniversityAtlantaGeorgia30322-
Illinois Retina Associates Rush UniversityChicagoIllinois60435-
University of ChicagoChicagoIllinois60637-
Midwest Eye InstituteIndianapolisIndiana46280-
Wilmer Eye Institute at Johns Hopkins University School of MedicineBaltimoreMaryland21287-
Ophthalmic Consultants of BostonBostonMassachusetts02114-
New England Retina Consultants, PCWest SpringfieldMassachusetts01089-
Retinal Consultants of NevadaLas VegasNevada89109-
University of New MexicoAlbuquerqueNew Mexico87131-
Duke Eye CenterDurhamNorth Carolina27710-
Eye Care Specialists, PCKingstonPennsylvania18704-
Southern New England Retina AssociatesProvidenceRhode Island02903-
Black Hills Regional Eye InstituteRapid CitySouth Dakota57701-

Find similar trials in Phoenix, AZ

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Retinal Consultants of Arizona· Phoenix, AZRetina-Vitreous Associates Medical Group· Beverly Hills, CAUniversity of Southern California· Los Angeles, CAEast Bay Retina Consultants· Oakland, CARetina Institute of California· Pasadena, CAUniversity of California, San Francisco· San Francisco, CA

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