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

China40 participantsStarted 2022-02-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with non-proliferative diabetic retinopathy (NPDR) meeting diagnostic criteria: the diagnosis can be made by fundus examination, fluorescein fundus angiography (FFA) and optical coherence tomography (OCT), which meet the clinical significant macular edema (CSME) definition criteria, i.e. hard exudation within 500μm of macular fovea with adjacent retinal thickening or edema within 500μm of macular fovea. Or the thickened area of the retina was \> 1 disc diameter (D) and within 1 day of 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 Criteria: * Patients with severe corneal opacity, cataract and vitreous hemorrhage were found to be affected by OCTA examination by ophthalmic examination. * Patients with other eye diseases or other complications during follow-up, such as glaucoma (IOP\>21mmHg), high myopia (≥-6.0D), and other fundus lesions, such as retinal detachment, 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 traction syndrome, proliferative diabetic retinopathy (PDR) resulting in vitre…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

central macular thickness (CMT)

Timeframe: up to 6 months

Trial details

NCT IDNCT05759884

SponsorSecond Affiliated Hospital, Zhejiang University, School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12

Contact for this trial

Zhiyong Zhang, MD. PhD.

13968059392 zhangzhiyong@zju.edu.cn

View on ClinicalTrials.gov More Macular Edema Due to Type 2 Diabetes Mellitus trials