Intravitreal and Intracameral DEX in NPDR

NCT06951087 | Enrolling By Invitation Phase 3 DMC

• 2 other identifiers: 2019-K06881974129, 82171038, 82101101
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Non-Proliferative Diabetic Retinopathy

Keywords

non-proliferative diabetic retinopathy; cataract phacoemulsification; cystoid macular edema

Outcome Measures

Primary Outcomes (1)

• measure the central point thickness (CPT) and central foveal thickness (CFT)

  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

  From enrollment to the end of treatment at 3 months

Study Arms (3)

intravitreal DEX group

EXPERIMENTAL

Patients received an intravitreal injection of 0.5 mg DEX during phacoemulsification in the intravitreal DEX group

Drug: Dexamethasone sodium phosphate

intracameral DEX group

EXPERIMENTAL

Patients received an intracameral injection of 0.5 mg DEX during phacoemulsification in the intracameral DEX group

Drug: Dexamethasone sodium phosphate

the control group

NO INTERVENTION

Patients received no injection during phacoemulsification in the control group

Interventions

Dexamethasone sodium phosphate DRUG

In patients with stable DR and no significant macular edema, intravitreal anti-VEGF injections after phacoemulsification surgery can prevent the worsening of postoperative macular edema and potentially improve final visual outcomes while maintaining safety. Laser coagulation and intravitreal anti-VEGF injections are currently considered the standard treatments for PDR. However, the cost of anti-VEGF drugs often prevents many patients from receiving regular and timely injections. Intravitreal corticosteroids may be used as an alternative to anti-VEGF agents.

intracameral DEX group; intravitreal DEX group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

Eye Institute, Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226001, China

Location

MeSH Terms

Conditions

Macular Edema

Interventions

dexamethasone 21-phosphate

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: April 30, 2025
• Study Start: January 31, 2022
• Primary Completion: April 20, 2025
• Study Completion: June 1, 2025
• Last Updated: April 30, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)