Effects of Adding Triamcinolone Acetonide to Conbercept Treatment for Refractory Diabetic Macular Edema (CONTE)

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study aimed to compare intravitreous conbercept alone with conbercept plus intravitreous triamcinolone acetonide in DME eyes which showed limited response to anti-VEGF treatment after one injection.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

Criteria

Inclusion Criteria:

• Type II diabetes

• Vison decrease was mainly caused by diabetic macular edema (DME)

• BCVA of 20/800 to 20/40 (decimal)

• Central subfield retinal thickness (CST) ≥ 300μm by optical coherence tomography (OCT) in the study eye

• Pan-retinal photocoagulation finished at least 3 months ago, or no pan-retinal photocoagulation is expected in the next 6 months

• Within the last 3 months, one intravitreous injection of anti-VEGF agent was performed, the CST reduction one month after injection was ≤ 20%.

Exclusion Criteria:

• Non-DME related macular edema, or edema control would not benefit the vision (for example, macular atrophy)

• Exist of other reasons of macular edema, retinal vein occlusion, uveitis, iris rubeosis, high myopia

• Ocular media opacity of insufficient quality to obtain OCT images and fundus images in the study eye

• Intraocular or periorbital injection of steroids within the last 3 months

• Macular grid photocoagulation within the last 4 months

• History of vitrectomy

• History of scleral buckle within the last 4 months, or intraocular surgery is expected in the next 6 months

• Any sign of ocular infection, including conjunctivitis, hordeolum, dacryocystitis

• Myocardial infarction, heart failure, stroke, or transient ischemic attack within one month

• Pregnant or breastfeeding women

• Uncontrolled hypertension, or blood pressure >180/110

• Patients with uncontrolled hyperglycemia, or Hemoglobin A1C (HbA1c) ≥10.0%, or under hemodialysis , or started insulin usage within the last 4 months, or expected to start insulin use for hyperglycemia control in the next 4 months

• Those cannot follow visits on time