diabetic macular edema
Conditions
Interventions
Drug injection group:?Intraocular injection of conbercept (0.5 mg, 0.05 mL), an anti-VEGF fusion protein injection, will be performed once a month. Regarding the method, antibiotic eye drops are appli
Laser group:Patients will undergo pan-retinal?photocoagulation using a 532 nm laser (Quantel Medical, France) in four sessions at an interval of 7 days. Pan-retinal?photocoagulation will be performed
Combined treatment group:Intraocular injection of conbercept (0.5 mg, 0.05 mL) will be given once a month for 3 consecutive months, during which pan-retinal?photocoagulation will be performed 3–4 time
Sponsors
Department of Ophthalmology, Affiliated Hospital of Beihua University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Type 1 or type 2 diabetic patients, as confirmed by the Standards of Medical Care in Diabetes—2023 issued by the American Diabetes Association, and patients with diabetic macular edema, as confirmed by fundus examination, fundus angiography, and OCT examination; (2) Patients with monocular lesions; (3) Patients with a central macular thickness = 250 µm based on OCT; (4) Best corrected visual acuity of 20–75 letters in the affected eye as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS).
Exclusion criteria
Exclusion criteria: 1.3.2Exclusion criteria (1) Patients undergoing any intraocular surgery (vitreous surgery, anti-VEGF treatment, etc.), retinal or macular laser photocoagulation, etc., within 6 months prior to admission; (2) Patients with other fundus diseases or active ocular infections (especially those with retinal and macular diseases, abnormalities in or damage to the central structures of the macula, etc.) or a past medical history of those; (3) Presence of iris rubeosis and neovascular glaucoma; (4) Patients with severe systemic diseases, such as severe cardiovascular, cerebrovascular, and renal insufficiency; (5) Patients with uveitis, glaucoma, and high myopia above -6.0 D; (6) Patients with mental disorders; (7) Patients with language communication disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Retinal ganglion cell-inner plexiform layer thickness for assessing the recovery from retinal ganglion cell damage; | — |
Secondary
| Measure | Time frame |
|---|---|
| Retinal nerve fiber layer thickness for assessing the recovery from retinal ganglion cell damage;Best-corrected visual acuity for assessing vision recovery;Macular area thickness used for assessing edema recovery;Choroidal thickness for assessing retinal function recovery;Retinal ganglion cell-inner plexiform layer thickness for assessing the recovery from retinal ganglion cell damage; | — |
Countries
China
Contacts
Public ContactXiangjun Li
Affiliated Hospital of Beihua University
Outcome results
None listed