Anti-VEGF Instead of Intraoperative PRP in Proliferative Diabetic Retinopathy

NCT ID: NCT03633266

Last Updated: 2018-08-17

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2022-12-01

Brief Summary

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

To evaluate the efficacy and safety of vitreoretinal surgery combined with anti-VEGF therapy in the replacement of intraoperative PRP in PDR therapy.

Detailed Description

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

Conditions

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

Anti-VEGF Proliferative Diabetic Retinopathy PRP Vitrectomy

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

NONE

Study Groups

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

anti-VEGF

experimental group: vitreoretinal surgery combined with intraoperative anti-VEGF

Group Type EXPERIMENTAL

anti-VEGF

Intervention Type PROCEDURE

vitreoretinal surgery combined with intraoperative anti-VEGF

PRP

Control group: vitreoretinal surgery combined with intraoperative PRP

Group Type ACTIVE_COMPARATOR

PRP

Intervention Type PROCEDURE

vitreoretinal surgery combined with intraoperative PRP

Interventions

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

anti-VEGF

vitreoretinal surgery combined with intraoperative anti-VEGF

Intervention Type PROCEDURE

PRP

vitreoretinal surgery combined with intraoperative PRP

Intervention Type PROCEDURE

Eligibility Criteria

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

Inclusion Criteria

1. Age≄18 years old;
2. type 1 or type 2 diabetes.
3. proliferative diabetic retinopathy with vitreous hemorrhage, and conservative treatment of vitreous hemorrhage without obvious absorption for 1 month requires vitreoretinal surgery;
4. The postoperative refractive medium is clear and the pupil is large enough to obtain sufficient clear fundus

Exclusion Criteria

1. Previously received panretinal photocoagulation or unfinished panretinal photocoagulation;
2. Pulling retinal detachment involving the macula or the presence of extensive fiber proliferation requires silicone oil filling;
3. anterior chamber neovascularization or neovascular glaucoma;
4. other vascular diseases such as retinal vein occlusion, arterial occlusion, etc;
5. received intraocular anti-VEGF therapy or triamcinolone acetonide treatment which are still in the treatment period.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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

Xiangtian Zhou

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yong Wei, M.D

Role: PRINCIPAL_INVESTIGATOR

The Eye Hospital of Wenzhou Medical University

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yong Wei, M.D

Role: CONTACT

+86 15057551266

Wei lin, M.D

Role: CONTACT

+86 13587560390

Other Identifiers

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

10007

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

Intravitreal Conbercept After Vitrectomy
NCT03426540 COMPLETED EARLY_PHASE1
Diabetic Retinopathy Study (DRS)
NCT00000160 COMPLETED PHASE3
Treating Early Stage Diabetic Retinopathy
NCT05132660 ENROLLING_BY_INVITATION EARLY_PHASE1