RELAND study

Phase 4

• Conditions: Diabetic Macular edema

• Registration Number: JPRN-jRCTs061180035
• Lead Sponsor: Kimura Kazuhiro

Brief Summary

A comparison of the change in visual acuity between ranibizumab plus local laser and ranibizumab monotherapy for non-responders to ranibizumab in DME patients showed no significant difference between the two groups. There was no significant difference in the number of doses of ranibizumab administered between the two groups.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-04
• Study Completion: 2021-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1)patients who have diabetes, and have developed in at
least one eye diabetic macular edema Patients
2)does not recognize the acute myocardial infarction and
cerebral infarction within the onset 3 months Patient age is greater than or equal to 20 years of age at the time of
3)obtaining informed consent
4)gender unquestioned
5)After having received a sufficient explanation Upon participation in the present study, patients on the full understanding, the document agreed by the free will of the patient himself was obtained
6)hospitalization, outpatient unquestioned

Exclusion Criteria

1)Patients with a treatment history of anti VEGF drugs
patients
2)Patients with infection or infection suspictions in the
eye or around the eye
3)Patients with severe inflammation in the eye
4)DME disease duration is more than 12 months
5)Patients who underwent direct photocoagulation to 3
months in DME within 1000um from the fovea
6)Patients who underwent triamcinolone acetonide subtenon
injection or triamcinolone acetonide intravitreal
injectionwithin 3 months
7)Patients who underwent PRP within 6 months
8)HbA1c is over 10.0%
9)Poor control of hypertension
10)Eye surgery within 6 months
11)ranibizumab or to the components of other anti-VEGF
drugs, those with a history of hypersensitivity
12)Pregnancy, in nursing
13)Other,patient research responsibility who is determined
to be unsuitable as research subjects

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The mean change from baseline in best corrected visual acuity (BCVA) at 6 month

Secondary Outcome Measures

Name	Time	Method
The mean change from baseline in central retinal thickness (CRT) based on SD-OCT at 6 month. The number of injections, and the number of laser treatment at 6 month.