NCT03863535

Brief Summary

The randomized clinical trial aims to compare the therapeutic effects between panretinal photocoagulation(PRP) and PRP combined with intravitreal conbercept (IVC) injection in severe nPDR with/without diabetic macular edema patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2019

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 5, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

March 5, 2019

Status Verified

March 1, 2019

Enrollment Period

2 years

First QC Date

January 27, 2019

Last Update Submit

March 3, 2019

Conditions

Severe Nonproliferative Diabetic RetinopathyDiabetic RetinopathyDiabete Mellitus

Keywords

ConberceptPanretinal photocoagulationnon-proliferative diabetic retinopathydiabetic macular edema

Outcome Measures

Primary Outcomes (1)

  • Change in best-corrected visual acuity (BCVA)

    To assess the effects of two therapies on visual acuity

    from baseline to month 12

Secondary Outcomes (3)

  • Change in central subfield thickness

    from baseline to month 12

  • Fundus fluorescein angiography

    from baseline to month 12

  • Foveal avascular zone

    from baseline to month 12

Study Arms (2)

Intravitreal conbercept+Panretinal coagulation

EXPERIMENTAL
Drug: ConberceptProcedure: Panretinal coagulation

Panretinal coagulation

ACTIVE COMPARATOR
Procedure: Panretinal coagulation

Interventions

ConberceptDRUG

Participants were randomized (1:1) to receive IVC+PRP or PRP monotherapy. Patients in IVC+PRP group with diabetic macular edema (DME) received 3 monthly IVC injections along with standard PRP within 1 week after the first injection. Those without DME received 1 lVC injection and standard PRP within 1 week after the injection . Re-treatments in both groups were at the investigators'discretion.

Intravitreal conbercept+Panretinal coagulation
Panretinal coagulationPROCEDURE

The PRP monotherapy group received standard PRP between day 1 and month 2; thereafter, re-treatments in both groups were at the investigators'discretion.

Intravitreal conbercept+Panretinal coagulationPanretinal coagulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type II diabetic patients, 18 years and older, were included if the participants had:
  • severe non-PDR in either eyes with/without diabetic macular edema;
  • ETDRS letters-measured best-corrected visual acuity (BCVA) ranging from 20/40 to 20/320 Snellen equivalent;
  • no previous treatment (of any type) in either eye.

You may not qualify if:

  • history of prior laser treatment or vitrectomy in the study eye;
  • history of thromboembolic event - including myocardial infarction or cerebral vascular accident;
  • major surgery within the prior 6 months or planned within the next 28 days;
  • history of glaucoma or ocular hypertension;
  • loss of vision as a result of other causes;
  • history of systemic corticosteroid therapy within the last 3 months;
  • severe systemic disease other than diabetes mellitus;
  • known coagulation abnormalities or current use of anticoagulative medication other than aspirin
  • any condition that could affect followup or documentation (including preretinal or vitreous hemorrhage).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 20025, China

RECRUITING

MeSH Terms

Conditions

Diabetic RetinopathyDiabetes Mellitus

Interventions

KH902 fusion protein

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Xi Shen, MD

    Ruijin Hospital

    STUDY DIRECTOR

  • Qiong Zhang, MD

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xi Shen, MD

CONTACT

+86-021-64370045carl_shen2005@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department director of Ophthamology

Study Record Dates

First Submitted

January 27, 2019

First Posted

March 5, 2019

Study Start

January 18, 2019

Primary Completion

January 1, 2021

Study Completion

September 30, 2021

Last Updated

March 5, 2019

Record last verified: 2019-03

Locations

CN(1)