Simultaneous subthreshold retinal-photocoagulation and intravitreal injection of VEGF inhibitors for diabetic macular edema

Phase 4

• Conditions: diabetic macular edema; Diabetic macular edema (DME)

• Registration Number: JPRN-jRCTs031180182
• Lead Sponsor: Tatsumi Tomoaki

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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-05
• Study Completion: 2020-10-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 51

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
11.Preretinal fibrosis extending to macular
12.Structural damage of central macular preventing improvement of visual acuity after regression of macular edema, such as atrophy of retinal pigment epithelium, subretinal fibrosis or scar, significant macular ischemia, or structural hard spot
13.Posibility of low vision to conduct medical or surgical interventions during the study period, complications which should affect the study result
14.Cataract surgery or other intraocular surgery within 90 days prior to the first dose
15.Capsulotomy after yttrium aluminum garnet (YAG)lesser treatment within 30 days prior to the first dose
16.Three or more times of Macular lesser treatment (excluding direct coagulation for microaneurysm), or judged no responder to lesser treatment
17.Subject has developed symptoms of infectious blepharitis, corneitis, leucitis or conjunctivitis
18.Insufficient degree of clearness of optic media for the fundus imaging and OCT imaging
19.Subject has treated for serious systemic infectious disease
20.Poor controlled hypertension (sitting systolic pressure > 160mmHg and/or diastolic pressure > 95mmHg
21.Renal failure indicating dialysis or renal transplantation
22.An event of cerebrovascular disease or myocardial infarction within 180 days prior to the first dose
23.Systemic treatment of angiogenic inhibitor within 180 days prior to the first dose
24. High risk subject, who will affect study results or develop complications, based on medical records, metabolic dysfunction, or laboratory test findings indicating a disease and/or conditions for that the test drug will be contraindicated
25.Allergy to fluorescein
26.Female subject who is pregnant or breastfeeding, or who hopes to become pregnancy during the study period
27.Subjects judged not to be adequate by the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A period before re-injection : A period before re-injection being necessary after the 3 consecutive monthly intravitreal injection of VEGF inhibitors