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

Diabetic Macula Edema Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02131350
• Other study ID #: 2617
• Status: Completed
• Phase: Phase 4
• Start date: April 2014
• Est. completion date: March 2018

Study information

• Verified date: September 2018
• Source: Shinshu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2018
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macula Edema
• Edema

Intervention

Procedure:
• Photocoagulation
Photocoagulation include focal/grid laser and/or panretinal photocoagulation

Drug:
• Ranibizumab

Locations

Country	Name	City	State
Japan	Department ou Ophthalmology Shinshu University School of Medicine	Matsumoto	Nagano

Sponsors (1)

Lead Sponsor	Collaborator
Shinshu University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	best corrected visual acuity	Best corrected visual acuity is measured with Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and analysed.	every month, up to 36 months