Intravitreal and Intracameral DEX in NPDR

NCT ID: NCT06951087

Last Updated: 2025-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-31

Study Completion Date

2025-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-Proliferative Diabetic Retinopathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

intravitreal DEX group

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

Group Type EXPERIMENTAL

Dexamethasone sodium phosphate

Intervention Type 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

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

Group Type EXPERIMENTAL

Dexamethasone sodium phosphate

Intervention Type 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.

the control group

Patients received no injection during phacoemulsification in the control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dexamethasone sodium phosphate

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Affiliated Hospital of Nantong University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Eye Institute, Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

81974129, 82171038, 82101101

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2019-K068

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.