Ranibizumab for Edema of the Macula in Diabetes: Protocol 3 With High Dose - the READ 3 Study

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Johns Hopkins University
Study ID
NCT01077401
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Ranibizumab — DRUG
    Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.
  • ranibizumab — DRUG
    Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.

Study Details

The purpose of this study is to investigate the safety, tolerability, bioactivity, and dose response of two different dosages (0.5 mg and 2.0 mg) of ranibizumab (RBZ) in patients with diabetic macular edema (DME).

Key Dates

First listed
Mar 1, 2010
Start date
Feb 28, 2010
Status verified
Mar 2017
Primary completion
Mar 31, 2012
Completion
Mar 31, 2013

Study Design

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

Arms

  • Experimental: Ranibizumab 0.5mg
    Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.
  • Experimental: Ranibizumab 2.0 mg
    Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.

Primary Outcome Measure

Deaths Due to Myocardial Infarction [ Time Frame: 6 Months ]

Locations (13)

FacilityCityStateZIPSite coordinators
Retina Vitreous AssociatesBeverly HillsCalifornia90211-
University of California San DiegoLa JollaCalifornia92037-
Doheny Eye InstituteLos AngelesCalifornia90033-
East Bay Retina InstituteOaklandCalifornia94609-
Retina Macula InstituteTorranceCalifornia90503-
Retina Group of FloridaFort LauderdaleFlorida33334-
Retina Institute of HawaiiHonoluluHawaii96815-
Illinois Retina AssociatesJolietIllinois60435-
University of KansasPrairie VillageKansas66208-
Johns Hopkins University Wilmer Eye InstituteBaltimoreMaryland21287-
Eye Care SpecialistsKingstonPennsylvania18704-
Black Hills Eye InstituteRapid CitySouth Dakota57701-
Texas Retina AssociatesArlingtonTexas76012-

Find similar trials in Beverly Hills, CA

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Retina Vitreous Associates· Beverly Hills, CAUniversity of California San Diego· La Jolla, CADoheny Eye Institute· Los Angeles, CAEast Bay Retina Institute· Oakland, CARetina Macula Institute· Torrance, CARetina Group of Florida· Fort Lauderdale, FL

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