Combination Treatment of Intravitreal Ranibizumab, Focal/Grid Laser and Panretinal Photocoagulation in Patients With Diabetic Macula Edema

Shinshu University

Status and phase: Completed; Phase 4

Conditions: Diabetic Macula Edema

Treatments: Procedure: Photocoagulation; Drug: Ranibizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT02131350

2617

Details and patient eligibility

About

The purpose of this study is to evaluate the mean gain in best corrected visual acuity and the number of intravitreal ranibizumab (IVR) injections under the combination treatment of IVR, focal/grid laser and panretinal photocoagulation. Our hypothesis is that suitable photocoagulation decreases the number of IVR injections.

Enrollment: 40 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• stable medication for the management of diabetes within 3 months
• visual impairment due to focal or diffuse diabetic macula edema
• decreased vision due to diabetic macula edema and not other causes

Exclusion criteria

• concomitant conditions in the study eye that could prevent the improvement in VA on the study
• active intraocular inflammation or infection in either eye
• uncontrolled glaucoma in either eye
• treatment with antiangiogenic drugs in the study eye within 3 months
• history of stroke and uncontrolled hypertension

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Ranibizumab with Photocoagulation

Experimental group

Treatment:

Drug: Ranibizumab

Procedure: Photocoagulation