Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02646670
Other study ID # ARVO R2 2016
Secondary ID
Status Completed
Phase Phase 4
First received December 2, 2015
Last updated January 3, 2016
Start date July 2015
Est. completion date November 2015

Study information

Verified date January 2016
Source Instituto de Olhos de Goiania
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial Summary

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.


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 GoiĆ¢nia)

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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date November 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Ranibizumab
- 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
- 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
- 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
- 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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Instituto de Olhos de Goiania

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy of Ranibizumab Therapy with Aflibercept in Patients with Diabetic Macular Edema Were evaluated the therapy with two different drugs used in diabetic retinopathy, and for this were separated twenty patients in four groups:
First group will be held three applications of intravitreal ranibizumab 0.1 ml, and follow up with OCT.
Second group will be held three applications of Intravitreal Aflibercept 0.1 ml, and followed by monitoring with OCT.
Third 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 OCT.
Fourth 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 OCT.
In all this groups will be observe the time of reduction of macular edema in the days 1, 3, 5, 10 and 30.
3 months Yes
See also
  Status Clinical Trial Phase
Recruiting NCT04968756 - Evaluating the Safety of the SPECTRALIS CENTAURUS Device N/A
Recruiting NCT01521065 - An Open-label Study to Evaluate the Clinical and Economic Benefits of I-Ray in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration Phase 2
Completed NCT00437593 - UHR-OCT and HD-OCT for Preretinal Membranes: ICG Versus Membrane Blue N/A
Completed NCT04919473 - Dose-Escalation Study to Evaluate the Safety and Tolerability of Intravitreal vMCO-I in Patients With Advanced Retinitis Pigmentosa Phase 1/Phase 2
Terminated NCT01225146 - Study of 2.0 mg Ranibizumab in Subjects With Ischemic Central Retinal Vein Occlusion (RAVE2) Phase 1
Completed NCT01205035 - High-Dose Lucentis (Ranibizumab 2.0mg) for the Treatment of Nonproliferative Idiopathic Parafoveal Telangiectasia Phase 2
Completed NCT00812760 - Effect of Levodopa on Human Multifocal Electroretinogram Phase 4
Active, not recruiting NCT06071546 - Clinical Investigation of a New Version of MAIA Microperimeter on Healthy Subjects and Patients With Retinal Pathology N/A
Completed NCT02946879 - Long-Term Follow-Up Gene Therapy Study for Leber Congenital Amaurosis OPTIRPE65 (Retinal Dystrophy Associated With Defects in RPE65)
Completed NCT01016873 - INTREPID - IRay Plus Anti-VEGF Treatment For Patients With Wet AMD Phase 2
Recruiting NCT04592068 - AI Classifies Multi-Retinal Diseases
Completed NCT01746563 - Intravitreal Ranibizumab Combined With Panretinal Photocoagulation in Patients With Proliferative Diabetic Retinopathy Phase 1/Phase 2
Completed NCT01399515 - Efficacy and Safety of Oral Valproic Acid for Retinitis Pigmentosa Phase 2
Terminated NCT02348359 - X-82 to Treat Age-related Macular Degeneration Phase 2
Completed NCT03954626 - Study to Collect Safety and ECG Data on Brolucizumab 6 mg Intravitreal Treatment in Patients With Wet AMD Phase 3
Completed NCT02582164 - Long-Working Distance OCT for Children N/A
Completed NCT01790958 - Microcurrent Stimulation to Treat Macular Degeneration N/A
Recruiting NCT05283941 - Pistachios and Neural Macular Pigment N/A
Completed NCT04678375 - Artificial Intelligence for Detecting Retinal Diseases
Completed NCT04902170 - Long-shaft Vitrectomy Probe in Highly Myopic Eyes N/A