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

Instituto de Olhos de Goiania

Status and phase: Completed; Phase 4

Conditions: Retinal Diseases

Treatments: Drug: Aflibercept; Drug: Ranibizumab and Aflibercept; Drug: Aflibercept and ranibizumab; Drug: Ranibizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT02646670

ARVO R2 2016

Details and patient eligibility

About

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.

Full description

Interventions will be carried out with intravitreal injections in patients with formal indications of diabetic macular edema treatment previously assessed with complete eye examination in Goiania Eye Institute(Instituto de Olhos de Goiânia)

Patients will be divided into four groups:

• 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 on days 1, 3, 5, 10 and 30 following the application.
• 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 on days 1, 3, 5, 10 and 30 subsequent
• 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 on days 1, 3, 5, 10 and 30.
• 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 on days 1, 3, 5, 10 and 30.

Enrollment: 20 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with Diabetic macular edema

Exclusion criteria

• patients without diabetic macular edema, or with diabetic macular edema with other disease that can make confuse about the diagnose

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 4 patient groups

Ranibizumab

Active Comparator group

Description:

- 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

Treatment:

Drug: Ranibizumab

Aflibercept

Active Comparator group

Description:

- 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

Treatment:

Drug: Aflibercept

Ranibizumab and Aflibercept

Active Comparator group

Description:

- 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

Treatment:

Drug: Ranibizumab and Aflibercept

Aflibercept and Ranibizumab

Active Comparator group

Description:

- 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

Treatment:

Drug: Aflibercept and ranibizumab