Intravitreal and Intracameral DEX in NPDR

Phase 3

• Conditions: Non-Proliferative Diabetic Retinopathy
• Interventions: Drug: Dexamethasone sodium phosphate

• Registration Number: NCT06951087
• Lead Sponsor: Affiliated Hospital of Nantong University

Brief Summary

To investigate the effects of intravitreal and intracameral injection of dexamethasone during cataract phacoemulsification in patients with mild to moderate non-proliferative diabetic retinopathy

Detailed Description

The study aims to analyze the impact of intravitreal and intracameral DEX in diabetic patients with NPDR who are undergoing phacoemulsification surgery. Specifically, the investigators will investigate its effects on postoperative macular central thickness, the development of DME, and the progression of DR.

Study Timeline

• Study Start: 2022-01-31
• Status Verified: 2024-12
• Study First Submitted: 2025-01-07
• Primary Completion: 2025-04-20
• Study First Submitted QC: 2025-04-22
• Last Update Submitted: 2025-04-22
• Study First Posted: 2025-04-30
• Last Update Posted: 2025-04-30
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

type 2 diabetic cataracts patients who were diagnosed with mild to moderate NPDR

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intravitreal DEX group	Dexamethasone sodium phosphate	Patients received an intravitreal injection of 0.5 mg DEX during phacoemulsification in the intravitreal DEX group
intracameral DEX group	Dexamethasone sodium phosphate	Patients received an intracameral injection of 0.5 mg DEX during phacoemulsification in the intracameral DEX group

Primary Outcome Measures

Name	Time	Method
measure the central point thickness (CPT) and central foveal thickness (CFT)	From enrollment to the end of treatment at 3 months	optical coherence tomography (OCT) was used to perform the retinal examination, macular cube scans (512 × 128) and measure the central point thickness (CPT) and central foveal thickness (CFT). The CPT measurement focused on a central circle with a diameter of 1mm, and the CFT was calculated as the average of three consecutive measurements

Trial Locations

Locations (1)

Eye Institute, Affiliated Hospital of Nantong University; 🇨🇳 Nantong, Jiangsu, China