Ranibizumab For Persistent Diabetic Macular Edema After Bevacizumab

Part of paid clinical trials in Augusta, Georgia.

Sponsor
Southeast Retina Center, Georgia
Study ID
NCT01845844
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Ranibizumab 0.3mg/0.05cc — DRUG
    Group A (Arm A) will receive monthly 0.3mg/0.05cc intravitreal injections for 12 consecutive months. Group B (Arm B) will receive monthly 0.3mg/0.05cc intravitreal injections for the first six months and then PRN for the remaining 6 months per protocol specified criteria.

Study Details

This is an open-label, Phase I/II study of Intravitreally administered 0.3mg ranibizumab in subjects with persistent Diabetic Macular Edema (DME) after recent and frequent bevacizumab (at least 2 bevacizumab intravitreal injections within 2 months prior to enrollment and at least 6 bevacizumab injections within 9 months of enrollment).

Key Dates

First listed
May 3, 2013
Start date
Apr 30, 2013
Status verified
Sep 2014
Primary completion
Jan 31, 2015
Completion
Jan 31, 2015

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ranibizumab 0.3mg (12 months)
    Intravitreal injection of ranibizumab 0.3mg/0.05cc
  • Active Comparator: Ranibizumab 0.3mg (6 months)
    Intravitreal injection of ranibizumab 0.3mg/0.05cc

Primary Outcome Measure

Incidence of ocular and systemic adverse events will be compared between experimental and active comparator groups [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Southeast Retina Center, PCAugustaGeorgia30909
Dennis M Marcus, MD
[email protected]
706-650-0061
Jared Gardner, BS
[email protected]
706-650-0061
Dennis M Marcus, M.D. (PRINCIPAL_INVESTIGATOR)
Harinderjit Singh, M.D. (SUB_INVESTIGATOR)

Find similar trials in Augusta, GA

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Southeast Retina Center, PC· Augusta, GA

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