The Effect of Intravitreal Ranibizumab on Visual Acuity and Hard Exudate Resolution in the Treatment of Diabetic Macular Edema With Center Involved Edema and Lipid Exudates

Part of paid clinical trials in Huntington Beach, California.

Sponsor
South Coast Retina Center; Carson, McBeath, Boswell, Inc.
Study ID
NCT02448446
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

Study Details

This is an open-label, Phase I/II study of intravitreally administered 0.3mg ranibizumab in subjects with diabetic macular edema and lipid exudates in the central subfield.

Key Dates

First listed
May 19, 2015
Start date
Aug 31, 2015
Status verified
Jul 2021
Primary completion
May 31, 2018
Completion
May 31, 2018

Study Design

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

Arms

  • Active Comparator: Diabetic macular edema treatment group (Group 1)
    Treatment using intravitreal ranibizumab 0.3mg based on the DRCR protocol I 4:2:7 strategy based on the presence of macular edema.
  • Active Comparator: Diabetic macular edema and lipid treatment group (Group 2)
    Continued treatment with intravitreal ranibizumab 0.3mg until, not only the macular edema is resolved, but also until the lipid exudate is resolved.

Primary Outcome Measure

Best Corrected Visual Acuity as Measured by ETDRS at 6 and 12 Months [ Time Frame: 6-12 months ]

Locations (4)

FacilityCityStateZIPSite coordinators
South Coast Retina Center; Carson, McBeath, Boswell, IncHuntington BeachCalifornia92647-
South Coast Retina Center; Carson, McBeath, and Boswell, IncLong BeachCalifornia90505-
Retina PartnersSanta MonicaCalifornia90404-
South Coast Retina Center; Carson, McBeath, Boswell, IncTorranceCalifornia90505-

Find similar trials in Huntington Beach, CA

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
South Coast Retina Center; Carson, McBeath, Boswell, Inc· Huntington Beach, CASouth Coast Retina Center; Carson, McBeath, and Boswell, Inc· Long Beach, CARetina Partners· Santa Monica, CASouth Coast Retina Center; Carson, McBeath, Boswell, Inc· Torrance, CA

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