Efficacy and Safety of Lucentis® Use in Patients With Diabetic Macular Edema Evaluating a Spaced Out Follow-up After Intensive Treatment Phase

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02032173
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Ranibizumab 0.5mg — DRUG
    Intravitreal injection with standard dose of 0.5 mg/0.05mL Pro re nata (PRN)

Study Details

The study was designed to assess the efficacy and safety of Lucentis® (ranibizumab 0.5 mg) in diabetic patients presenting with reduced visual acuity due to diabetic macular edema and evaluating spacing out of follow-up after initial intensive treatment phase.

Key Dates

First listed
Jan 9, 2014
Start date
May 19, 2014
Status verified
Sep 2020
Primary completion
Apr 29, 2015
Completion
Apr 29, 2015

Study Design

Enrollment
31 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ranibizumab 0.5mg
    Intravitreal injection with standard dose of 0.5 mg/0.05mL Pro re nata (PRN)

Primary Outcome Measure

Number of Participants With a Stable BCVA in the Study Eye at 24 Months Compared With BCVA at 6 Months [ Time Frame: Month 6 and 24 ]

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