Combined aPproach to Treatment Using Ranibizumab and Efalizumab for Diabetic Macular Edema Study: The CAPTURE DME Study

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Johns Hopkins University
Study ID
NCT00676559
Phase
PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • Efalizumab — DRUG
    Efalizumab 1 mg/kg weekly subcutaneous self-administered injections for 48 weeks.
  • Ranibizumab — DRUG
    Ranibizumab 0.5 mg intravitreal injections monthly for three months followed by criteria-guided monthly injections through Month 11 (inclusive).

Study Details

This study looks to continue the study of anti-vegf therapy in patients with macular edema, and compare it to an anti-inflammatory therapy and a combined Anti-vegf and anti-inflammatory.

Key Dates

First listed
May 13, 2008
Start date
Apr 30, 2008
Status verified
Aug 2016
Primary completion
Apr 30, 2009
Completion
Apr 30, 2010

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1
    Efalizumab 1 mg/kg weekly subcutaneous self-administered injections for 48 weeks.
  • Experimental: Group 2
    Ranibizumab 0.5 mg intravitreal injections monthly for three months followed by criteria-guided monthly injections through Month 11 (inclusive).
  • Experimental: Group 3
    Efalizumab 1 mg/kg weekly subcutaneous self-administered injections for 48 weeks in combination with ranibizumab 0.5 mg intravitreal injections monthly for three months followed by criteria-guided monthly injections through Month 11 (inclusive).

Primary Outcome Measure

To assess the safety and tolerability of efalizumab, compared to and in combination with ranibizumab, measuring the frequency and severity of adverse events. [ Time Frame: 6 mos ]

Locations (10)

FacilityCityStateZIPSite coordinators
Diego H. Calonje, M.D., P.C.TucsonArizona85712-
Sharp Rees-Stealy Medical GroupSan DiegoCalifornia92101-
Retina Macula InstituteTorranceCalifornia90503-
Retina Associates of MaineBangorMaine04401-
Retina Center of MaineSouth PortlandMaine04106-
Wilmer Eye Institute at the Johns Hopkins UniversityBaltimoreMaryland21287-
Ophthalmic Consultants of BostonBostonMassachusetts02114-
Eye Care SpecialistsKingstonPennsylvania18704-
Texas Retina AssociatesArlingtonTexas76012-
University of UtahSalt Lake CityUtah84132-

Find similar trials in Tucson, AZ

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Diego H. Calonje, M.D., P.C.· Tucson, AZSharp Rees-Stealy Medical Group· San Diego, CARetina Macula Institute· Torrance, CARetina Associates of Maine· Bangor, MERetina Center of Maine· South Portland, MEWilmer Eye Institute at the Johns Hopkins University· Baltimore, MD

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