Efficacy of Ranibizumab Therapy With Aflibercept in Patients With Diabetic Macular Edema

Sponsor
Instituto de Olhos de Goiania
Study ID
NCT02646670
Phase
PHASE4
Status
Completed

Conditions

  • Retinal Diseases

Eligibility Criteria

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

Interventions

  • Ranibizumab — DRUG
    \- In the first group will be held three applications of intravitreal ranibizumab 0.1 ml, with one application every month and follow up with Optical Coherence Tomography
  • Aflibercept — DRUG
    \- In the second group will be held three applications of Intravitreal Aflibercept 0.1 ml, with one application each month followed by monitoring with Optical Coherence Tomography
  • Ranibizumab and Aflibercept — DRUG
    \- The third group will be held two applications of Ranibizumab 0.1 ml interspersed with one application of Aflibercept 0.1 ml in the second month and subsequent evaluation with Optical Coherence Tomography
  • Aflibercept and ranibizumab — DRUG
    \- In the fourth group will be held two applications of 0.1 ml Aflibercept interspersed with one application of Ranibizumab 0.1 ml in the second month and subsequent evaluation with Optical Coherence Tomography

Study Details

The purpose of this study in to compare the efficacy of treatment of diabetic macular edema (DME) using Ranibizumab (Lucenti®), Aflibercept (Eylea®) and Aflibercept (Eylea®) plus Ranibizumab (Lucentis®). It is a randomized clinical trial that will evaluate the efficacy of the combination of two substances currently used in the treatment of DME. Will be allocated in different four groups randomly pacients who receive treatment with intravitreal injections of ranibizumab, aflibercept or a combination of aflibercept and ranibizumab.

Key Dates

Start date
Jul 31, 2015
Status verified
Jan 2016
Primary completion
Oct 31, 2015
Completion
Nov 30, 2015

Study Design

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

Arms

  • Active Comparator: Ranibizumab
    \- In the first group will be held three applications of intravitreal ranibizumab 0.1 ml . This group will be five about patients about any age, with diabetic macular edema randomly chosen
  • Active Comparator: Aflibercept
    \- In the second group will be held three applications of Intravitreal Aflibercept 0.1 ml. This group will be about five patients about any age, with diabetic macular edema randomly chosen
  • Active Comparator: Ranibizumab and Aflibercept
    \- In this group will be held two applications of 0.1 ml Aflibercept(the first and the third doses) interspersed with one application of Ranibizumab 0.1 ml(the second dose). This group will be about five patients about any age, with diabetic macular edema randomly chosen
  • Active Comparator: Aflibercept and Ranibizumab
    \- This group will be held two applications of Ranibizumab 0.1 ml(the first and the third doses) interspersed with one application of Aflibercept 0.1 ml(the second dose). This group will be five about patients about any age, with diabetic macular edema randomly chosen

Primary Outcome Measure

Efficacy of Ranibizumab Therapy with Aflibercept in Patients with Diabetic Macular Edema [ Time Frame: 3 months ]

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