Exploratory clinical study to examine the efficacy of the simultaneous subthreshold retinal-photocoagulation and the intravitreal injection of VEGF inhibitors for diabetic macular edema - Simultaneous subthreshold retinal-photocoagulation and intravitreal injection of VEGF inhibitors for DME

Tatsumi Tomoaki0 sites51 target enrollmentMarch 5, 2019

Conditionsdiabetic macular edema Diabetic macular edema (DME)

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: diabetic macular edema
Sponsor: Tatsumi Tomoaki
Enrollment: 51
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

A prospective randomized controlled trial was conducted to examine the efficacy and safety of treatment for diabetic macular edema in two groups, an anti-VEGF treatment monotherapy group and combination therapy group of a anti-VEGF treatment and subthreshold laser. There was no significant difference in the number of anti-VEGF injections, CRT, and BCVA(logMAR) between the monotherapy group and the combination therapy group, and no additional effect was observed on the improvement of diabetic macular edema.

Registry

who.int

Start Date

March 5, 2019

End Date

October 31, 2020

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Tatsumi Tomoaki

Eligibility Criteria

Inclusion Criteria

•1\. Japanese male and female \>\= 18 years with type 1 or 2 diabetes mellitus
•2\. DME with central involvement in the study eye
•3\. Decrease in vision determined to be primarily the result of DME in the study eye
•4\. central macular thickness \>\= 300 micrometer in the study eye
•5\. BCVA of 0\.7 to 0\.05 in the study eye
•6\. Subject must be competent to understand the information ICF and must sign the form
•7\. An eye with thicker patina when both eyes meet the above criteria

Exclusion Criteria

•1\.Laser photocoagulation (panretinal or macular) in the study eye within 90 days prior to the first dose
•2\.Previous use of intraocular or periocular corticosteroids in the study eye within 120 days prior to the first dose
•3\.Previous treatment with anti\-angiogenic drugs in the study eye (pegaptanib sodium, bevacizumab, ranibizumab, etc.) within 90 days prior to the first dose
•4\.Active proliferative diabetic retinopathy (PDR) in the study eye
•5\.Uncontrolled diabetes mellitus
•6\.Medical history of vitreoretinal surgery and scleral buckling
•7\.Medical history of filtering operation for glaucoma treatment and subject is expected to treat that operation in future
•8\.Medical history of idiopathic or autoimmune uveitis
•9\.Central vision is significantly affected by existing Vitreous tug syndrome or preretinal membrane
•10\.Existing iris neovascularization, vitreous hemorrhage and/or traction retinal detachment