Efficacy Analysis of Anti-VEGF Drugs Combined With Micropulse Laser in the Treatment of Diabetic Macular Edema

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/A

Clinical Study ID

NCT05759884
2022-0022
  • Ages > 18
  • All Genders

Study Summary

The goal of this clinical trial is to clarify the efficacy of anti-vascular endothelial growth factor (anti-VEGF) drugs combined with subthreshold micropulse laser (SML) therapy on retinal function and anatomical recovery in patients with diabetic macular edema (DME). The main questions it aims to answer are:

  • To clarify the efficacy of anti-VEGF drugs combined with SML therapy on retinal function and anatomical recovery in DME patients.

  • To explore the changes in visual acuity and optical coherence tomography angiography (OCTA) parameters before and after the treatment of DME with anti-VEGF drugs combined with SML, and further explore the changes in morphological characteristics of retinal microvessels and the potential treatment mechanism.

Participants will randomly be given Intravitreous injection of anti-VEGF drugs or anti-VEGF drugs combined with SML therapy. All participants will be followed up for 6 months after treatment.

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
    China

    Active - Recruiting

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