Last updated: February 26, 2023
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Overall Status: Active - Recruiting
Phase
N/A
Condition
Diabetes Mellitus, Type 2
Macular Edema
Treatment
N/AClinical Study ID
NCT05759884
2022-0022
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients with non-proliferative diabetic retinopathy (NPDR) meeting diagnosticcriteria: the diagnosis can be made by fundus examination, fluorescein fundusangiography (FFA) and optical coherence tomography (OCT), which meet the clinicalsignificant macular edema (CSME) definition criteria, i.e. hard exudation within 500μmof macular fovea with adjacent retinal thickening or edema within 500μm of macularfovea. Or the thickened area of the retina was > 1 disc diameter (D) and within 1 dayof the fovea of the macula.
- OCT examination showed a thickened CMT (≥200μm) without hyperplasia or scar
- Standard logarithmic visual acuity charts measure the BCVA (LogMAR) range from 0.01 to 1.0
- Control of glycosylated hemoglobin (HbA1c) ≤10% during follow-up
- Patients voluntarily participate and sign informed consent
Exclusion
Exclusion Criteria:
- Patients with severe corneal opacity, cataract and vitreous hemorrhage were found tobe affected by OCTA examination by ophthalmic examination.
- Patients with other eye diseases or other complications during follow-up, such asglaucoma (IOP>21mmHg), high myopia (≥-6.0D), and other fundus lesions, such as retinaldetachment, vitreous macular traction, preretinal membrane, ischemic macular disease,optic neuritis and other diseases involving the retina and optic nerve.
- Patients who have previously received intraocular surgery, vitreous macular tractionsyndrome, proliferative diabetic retinopathy (PDR) resulting in vitreous hemorrhage orlocal retinal detachment requiring surgical treatment, and patients with a history ofeye trauma.
- History of panretinal photocoagulation within 6 months prior to treatment orlocal/grille photocoagulation within 3 months prior to treatment.
- History of intravitreal injection of any steroid within 6 months prior to treatment.
- Patients with serious systemic diseases, such as cardiovascular and cerebrovasculardiseases or hematopoietic system, patients who have undergone intracranial surgery orintracranial space-occupying lesions, and patients with mental disorders.
- Can not cooperate with the ophthalmic examination or other reasons can not obtain theideal OCTA image.
- Pregnant, pregnant or lactating women and patients allergic to drugs.
- Suspected or confirmed history of alcohol and drug abuse.
- Patients who are participating in clinical trials of other drugs. If one of the abovemeets and can be excluded.
Study Design
Total Participants: 40
Study Start date:
February 01, 2022
Estimated Completion Date:
June 30, 2024
Connect with a study center
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang 310000
ChinaActive - Recruiting

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