Safety and Efficacy of Ranibizumab for Diabetic Macular Edema

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Justis Ehlers
Study ID
NCT01982435
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Ranibizumab — DRUG
    Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema.
  • Ranibizumab — DRUG
    Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months.

Study Details

The primary objective of the study is to assess the ocular and systemic adverse events of ranibizumab (Lucentis)for DME (diabetic macular edema) following previous treatment with intravitreal bevacizumab (Avastin).

Key Dates

First listed
Nov 13, 2013
Start date
Jun 24, 2014
Status verified
Oct 2020
Primary completion
May 26, 2016
Completion
May 26, 2016

Study Design

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

Arms

  • Other: Group I - Monthly
    Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group.
  • Other: Group II - Treat-and-Extend
    Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results.

Primary Outcome Measure

Number of Participants With Non-severe Ocular Adverse Events [ Time Frame: 12 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Cole Eye Institute, Cleveland ClinicClevelandOhio44195-
Cole Eye Institute at Hillcrest HospitalMayfield HeightsOhio44124-

Find similar trials in Cleveland, OH

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Cole Eye Institute, Cleveland Clinic· Cleveland, OHCole Eye Institute at Hillcrest Hospital· Mayfield Heights, OH

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