Multicenter Clinical Study of Anti-VEGF Treatment on High Risk Diabetic Retinopathy (DR)

NCT03452657 | Unknown Phase 3

• 1 other identifier: DLY201612
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to determine the efficacy and safety of intravitreous ranibizumab treatment versus sham injections for prevention of high-risk DR.

Conditions

Diabetic Retinopathy; Ranibizumab

Outcome Measures

Primary Outcomes (1)

• Proportion of eyes with a ≥ 2-step improvement in the ETDRS Diabetic Retinopathy Severity Scale (DRSS) score

  Baseline ETDRS DRSS: None (level 10); Mild to moderate nonproliferative DR (levels 14, 15, 20, 35, and 43); Moderately severe/severe nonproliferative DR (levels 47 and 53); Mild/moderate/high-risk/advanced proliferative DR (levels 61, 65, 71,75, 81, and 85)

  1 year

Secondary Outcomes (3)

• Change from baseline in CRT (central retinal thickness)

  1 year

• Mean change from baseline in best-corrected visual acuity (BCVA)

  1 year

• Proportion of eyes that meet the protocol-defined failure criteria

  1 year

Study Arms (2)

Ranibizumab

EXPERIMENTAL

Participants received 0.5mg intravitreal ranibizumab injection

Drug: Ranibizumab

Sham-injection

SHAM COMPARATOR

No drug involved in the sham procedure; patient's eye is anesthetized and a syringe without needle gently pressed on the conjunctival surface to simulate the force of an actual injection

Procedure: No drug

Interventions

Ranibizumab DRUG

Participants in arm Ranibizumab will receive ranibizumab injection every 4 weeks for the first 3 months, followed by re-injections every 3 months until 1year

Also known as: Lucentis

Ranibizumab

No drug PROCEDURE

Participants in arm Sham-injection will receive sham injection every 4 weeks for the first 3 months, followed by re-injections every 3 months until 1year.

Sham-injection

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>= 18 years;
• Diagnosis of diabetes mellitus (type 1 or type 2);
• The fundus color photography was graded by Reading Center as grade 47-53;
• Patients have not received Pan Retinal Photocoagulation (PRP: laser spots on fundus outside hemal arch are less than 100);
• HbA1C≤ 10%;
• Media clarity and pupillary dilation sufficient to obtain adequate fundus examinations;
• No central subfield macular edema.

You may not qualify if:

• Ocular infection, including conjunctivitis, chalazion, or substantial blepharitis;
• Proliferative diabetic retinopathy;
• History of prior vitreous hemorrhage within 2 months;
• An ocular condition is presented (other than DR), (e.g., retinal vein or artery occlusion, CNV, retinal detachment, macular hole, vitreomacular traction, etc.);
• Evidence of iris neovascularization;
• Evidence of uncontrolled glaucoma( Intraocular pressure \>25 mmHg with glaucoma medication) or history of anti-glaucoma surgery;
• Server cataract that influences judgment or needs cataract surgery in 6 months;
• Aphakia;
• Received other ocular treatment:
• History of intravitreal injection of corticosteroid within 3 months, or peribulbar injection of corticosteroid within 1 month;
• History of vitreous surgery;
• History of PRP ≥ 2 times or within 6 months in the study eye;
• History of focal laser treatment within 3 months or laser treatment involving fovea ≥ 2 times in the past in the study eye;
• History of anti-VEGF treatment within 6 months in the study eye or history of anti-VEGF treatment within 3 months in the non-study eye;
• History of any intraocular surgery within 3 months;

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead
• RenJi Hospital: collaborator
• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Eye & ENT Hospital of Fudan University: collaborator
• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: collaborator
• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: collaborator
• Shanghai 10th People's Hospital: collaborator
• Shanghai Tongji Hospital, Tongji University School of Medicine: collaborator

Study Sites (7)

Eye and ENT hospital of Fudan University

Shanghai, China

Location

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, China

Location

Shanghai ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, China

Location

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University

Shanghai, China

Location

Shanghai Tenth People's Hospital of Tongji University

Shanghai, China

Location

Shanghai Tongji Hospital of Tongji University

Shanghai, China

Location

Xinhua Hospital Afflilliated to Shanghai Jiaotong University School of Medicine

Shanghai, China

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Xun Xu

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  STUDY CHAIR

Central Study Contacts

Kun Liu

CONTACT

+86 18917989522; drkunliu@sjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Professor

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: March 2, 2018
• Study Start: April 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2020
• Last Updated: March 2, 2018

Record last verified: 2018-03

Locations

CN (7)