Clinical trial to evaluate the efficacy and safety of SRT(Selective Retina Therapy) in patients with Diabetic Macular Edema

Not Applicable

Active, not recruiting

• Conditions: Diseases of the eye and adnexa

• Registration Number: KCT0001415
• Lead Sponsor: The Catholic University of Korea, Yeouido St. Mary's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

1)Adults older than 19 years
2)Patients with type II diabetes without a history of ophthalmological treatment
3)Patients who were diagnosed with clinically significant Diabetic Macular Edema based on the criteria of ETDRS (Early Treatment Diabetic Retinopathy Study)
4)Patients with decreased visual acuity
5)Patients with focal edema or patchy diffuse edema
6)Patients who agreed to participate in this study and signed or whose legally acceptable representative signed the Informed Consent Form

Exclusion Criteria

1)Patients with ischemic Diabetic Macular Edema that showed rupture in the foveal avascular zone due to the obstruction of more than 30% of the capillary vessels in the central circle, as observed using fluorescein fundus angiography
2)Patients with rubeosis iridis
3)Patients who cannot be treated with laser due to their cataract or vitreous opacity
4)Patients with a history of intra-ocular surgery
5)Patients with a history of focal steroid treatment, injection of anti-VEGF agents, or focal or grid laser exposure of their macular area within 4 months (including Pan retinal photocoagulation)
6)Patients with glaucoma or other retinal vascular diseases
7)Patients with confirmed allergy to fluorescein, indocyanine green, or iodine
8)Patients with clinically significant diseases such as renal failure based on the investigator’s judgment
9)Patients who are pregnant, breastfeeding, or planning to be pregnant
10)Patients with other conditions that would make it difficult for them to participate in this study, based on the investigator’s judgment

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Best Corrected Visual Acuity

Secondary Outcome Measures

Name	Time	Method
Retinal Thickness;Exudate;Visual field sensitivity;Adverse events, slit lamp biomicroscopy results, vital signs, and laboratory test results for safety