NCT02328118

Brief Summary

Proliferative diabetic retinopathy(PDR) is the leading cause of visual loss in diabetic patients. Operation is an efficient method to treat PDR. Anti-vascular endothelial growth factor (anti-VEGF) can be used as an adjuvant therapy which can make operation more easy.

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
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2015

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

First Submitted

Initial submission to the registry

December 20, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 31, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

August 25, 2016

Status Verified

August 1, 2016

Enrollment Period

2.1 years

First QC Date

December 20, 2014

Last Update Submit

August 23, 2016

Conditions

Proliferative Diabetic Retinopathy

Keywords

LucentisRanibizumabTriamcinolone AcetonideVitrectomyPDR

Outcome Measures

Primary Outcomes (1)

  • composite outcome including amotio retinae,vitreous hemorrhage within 12 months after vitrectomy

    12 months after the last subject accepts vitrectomy

Secondary Outcomes (2)

  • the change of Best-corrected visual acuity

    the change of best-corrected visual acuity at month 12 after vitrectomy

  • the change of inflammatory factors in vitreous body

    7 days after injection

Study Arms (2)

Ranibizumab 0.5 mg

EXPERIMENTAL

All subjects in this group will receive Ranibizumab (0.5mg/0.05ml) intravitreal injection.

Drug: RanibizumabDrug: Triamcinolone Acetonide

Triamcinolone Acetonide 4mg

EXPERIMENTAL

All patients in this group will receive Triamcinolone Acetonide(4mg/0.1ml) during operation.

Drug: Triamcinolone Acetonide

Interventions

RanibizumabDRUG

A week before 25-gauge vitrectomy, all subjects in Ranibizumab group will receive Ranibizumab 0.5mg/0.05 ml intravitreal injection. All patients in this group will receive Triamcinolone Acetonide(4mg/0.1ml) during operation.

Also known as: Lucentis, rhuFab V2
Ranibizumab 0.5 mg
Triamcinolone AcetonideDRUG

A week before 25-gauge vitrectomy, all subjects in Triamcinolone Acetone group will receive Triamcinolone Acetone 4mg/0.1 ml intravitreal injection. All patients in this group will receive Triamcinolone Acetonide(4mg/0.1ml) during operation.

Also known as: Vitreal S, Cinonide, Tricort 40, Kenalog
Ranibizumab 0.5 mgTriamcinolone Acetonide 4mg

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type II diabetes mellitus with Diabetic Retinopathy
  • Vitreous hemorrhage/Proliferation of retinal/Tractional detachment of retina
  • Fasting blood-glucose no more than 8mmol/ml

You may not qualify if:

  • Subjects who have operation on vitreous before
  • Accompany with other ophthalmology diseases except cataract
  • History of vitrectomy surgery in the study eye
  • Previous subfoveal focal laser photocoagulation in the study eye
  • Previous participation in a clinical trial (for either eye)
  • Previous subfoveal focal laser photocoagulation in the study eye
  • Other diseases cannot afford Vitrectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First People Hospital of Xuzhou

Xuzhou, Jiangsu, 221002, China

RECRUITING

Related Publications (10)

  • Guthoff R, Riederle H, Meinhardt B, Goebel W. Subclinical choroidal detachment at sclerotomy sites after 23-gauge vitrectomy: analysis by anterior segment optical coherence tomography. Ophthalmologica. 2010;224(5):301-7. doi: 10.1159/000298750. Epub 2010 Mar 23.

    PMID: 20332654BACKGROUND

  • Dehghan MH, Salehipour M, Naghib J, Babaeian M, Karimi S, Yaseri M. Pars plana vitrectomy with internal limiting membrane peeling for refractory diffuse diabetic macular edema. J Ophthalmic Vis Res. 2010 Jul;5(3):162-7.

    PMID: 22737351BACKGROUND

  • Cho M, D'Amico DJ. Transconjunctival 25-gauge pars plana vitrectomy and internal limiting membrane peeling for chronic macular edema. Clin Ophthalmol. 2012;6:981-9. doi: 10.2147/OPTH.S33391. Epub 2012 Jul 6.

    PMID: 22848140BACKGROUND

  • Song SJ, Sohn JH, Park KH. Evaluation of the efficacy of vitrectomy for persistent diabetic macular edema and associated factors predicting outcome. Korean J Ophthalmol. 2007 Sep;21(3):146-50. doi: 10.3341/kjo.2007.21.3.146.

    PMID: 17804919BACKGROUND

  • Gupta V, Arevalo JF. Surgical management of diabetic retinopathy. Middle East Afr J Ophthalmol. 2013 Oct-Dec;20(4):283-92. doi: 10.4103/0974-9233.120003.

    PMID: 24339677BACKGROUND

  • Shamsi HN, Masaud JS, Ghazi NG. Diabetic macular edema: New promising therapies. World J Diabetes. 2013 Dec 15;4(6):324-38. doi: 10.4239/wjd.v4.i6.324.

    PMID: 24379924BACKGROUND

  • Romero-Aroca P. Managing diabetic macular edema: The leading cause of diabetes blindness. World J Diabetes. 2011 Jun 15;2(6):98-104. doi: 10.4239/wjd.v2.i6.98.

    PMID: 21860693BACKGROUND

  • Bainbridge J. Refractory diabetic macular edema. J Ophthalmic Vis Res. 2010 Jul;5(3):143-4. No abstract available.

    PMID: 22737347BACKGROUND

  • Jahn CE, Topfner von Schutz K, Richter J, Boller J, Kron M. Improvement of visual acuity in eyes with diabetic macular edema after treatment with pars plana vitrectomy. Ophthalmologica. 2004 Nov-Dec;218(6):378-84. doi: 10.1159/000080940.

    PMID: 15564755BACKGROUND

  • Robaszkiewicz J, Chmielewska K, Wierzbowska J, Figurska M, Frontczak-Baniewicz M, Stankiewicz A. [Combined surgical and pharmacological treatment of diabetic maculopathy]. Klin Oczna. 2010;112(1-3):19-23. Polish.

    PMID: 20572497BACKGROUND

MeSH Terms

Interventions

RanibizumabTriamcinolone Acetonide

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTriamcinolonePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • SUYAN LI, doctor

    Ophthalmology Department of the 1st People Hospital of Xuzhou

    PRINCIPAL INVESTIGATOR

Central Study Contacts

SUYAN LI, Doctor

CONTACT

+86-13852101175lisuyan1226@126.com

JUNYAN ZHANG, bachelor

CONTACT

+86-13701739364richard.zhang@both-win.net

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Consultant and Statistician

Study Record Dates

First Submitted

December 20, 2014

First Posted

December 31, 2014

Study Start

February 1, 2015

Primary Completion

March 1, 2017

Study Completion

May 1, 2017

Last Updated

August 25, 2016

Record last verified: 2016-08

Locations

CN(1)