NCT03973138

Brief Summary

The aim of this study is to evaluate the one-year visual outcome and prognostic factors after intraocular injections of ranibizumab under pro re nata treatment regimen for the patients with diabetic macular edema (DME).

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
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2015

Longer than P75 for phase_1

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 1, 2015

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

June 4, 2019

Status Verified

June 1, 2019

Enrollment Period

5 years

First QC Date

June 2, 2019

Last Update Submit

June 2, 2019

Conditions

Diabetic Macular Edema

Keywords

Macular edemaranibizumabMpredictive factor

Outcome Measures

Primary Outcomes (1)

  • Best-corrected visual acuity

    changes of best-corrected visual acuity

    one year

Secondary Outcomes (1)

  • Central foveal thickness

    one year

Study Arms (1)

Treatment group

EXPERIMENTAL

DME patients who were diagnosed through fundus manifestations and FFA examination were treated by intravitreal injections of ranibizumab under the pro re nata (PRN) treatment regimen.

Drug: Ranibizumab

Interventions

RanibizumabDRUG

DME patients who were diagnosed through fundus manifestations and FFA examination were treated by intravitreal injections of ranibizumab (0.5mg Lucentis®; Genentech, South San Francisco, CA) under the pro re nata (PRN) treatment regimen. The retreatment were conducted if BCVA was reduced by 0.1 logarithm of the minimal angle of resolution (logMAR) value or more from maximum acuity or if OCT central subfield thickness was more than 300μm.

Treatment group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) patients (aged\>18 years) with DME who had a best-corrected visual acuity (BCVA) between 20/32 and 20/200, and CRT≥300μm; 2) clinically significant DME confirmed by both fundus fluorescein angiography (FFA) and optical coherence tomography (OCT) (Spectralis HRA+OCT; Heidelberg Engineering, Germany); 3) decreased vision caused by foveal thickening from DME, which could not be explained by any other cause.

You may not qualify if:

  • \) previous anti-VEGF or laser treatment; 2) proliferative diabetic retinopathy who required immediate panretinal photocoagulation; 3) active proliferative diabetic retinopathy; 4) other causes for macular edema, for example, branch retinal vein occlusion; 5) other causes of visual loss in the study; 6) unstable systemic conditions, for example, uncontrolled blood pressure, stroke, renal or kidney failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kunbei Lai

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (1)

  • Lai K, Huang C, Li L, Gong Y, Xu F, Zhong X, Lu L, Jin C. Anatomical and functional responses in eyes with diabetic macular edema treated with "1 + PRN" ranibizumab: one-year outcomes in population of mainland China. BMC Ophthalmol. 2020 Jun 15;20(1):229. doi: 10.1186/s12886-020-01510-0.

    PMID: 32539744DERIVED

MeSH Terms

Conditions

Macular Edema

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Chenjin Jin, ph.D.

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    STUDY CHAIR

Central Study Contacts

Kunbei Lai

CONTACT

8602087331366laikb@163.com

Chenjin Jin, ph.D.

CONTACT

13302209900jinchj@126.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 2, 2019

First Posted

June 4, 2019

Study Start

January 1, 2015

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

June 4, 2019

Record last verified: 2019-06

Locations

CN(1)