25-G Vitrectomy With Ranibizumab or Triamcinolone Acetonide on PDR in China-Randomized Clinical Trial
aiRTo-PDR
25-Gauge Vitrectomy With Ranibizumab or Triamcinolone Acetonide on Proliferative Diabetic Retinopathy in China: a Randomized, Single Blind Trial
1 other identifier
interventional
200
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2015
Longer than P75 for phase_3
1 active site
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
May 14, 2015
CompletedFirst Posted
Study publicly available on registry
May 18, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedSeptember 24, 2018
September 1, 2018
5.5 years
May 14, 2015
September 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
intraoperative bleeding
during operation of 25-G Vitrectomy
Secondary Outcomes (3)
composite outcomes including amotio retinae,vitreous hemorrhage within 12 months after vitrectomy
12 months after the last subject accepts vitrectomy
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 the first injection
Study Arms (2)
Ranibizumab
EXPERIMENTALA week before 25-gauge vitrectomy, all subjects in Ranibizumab group will receive Ranibizumab 0.5mg/0.05 ml intravitreal injection. During operation all subjects in this group will be injected Triamcinolone Acetonide 4 mg/0.1ml. All subjects in this group will get Ranibizumab 0.2 mg/0.02 ml intravitreal injection just after the operation.
Triamcinolone Acetonide
ACTIVE COMPARATORA week before 25-gauge vitrectomy, all subjects in Triamcinolone Acetonide group will receive Triamcinolone Acetonide 4mg/0.1 ml intravitreal injection. During operation all subjects in this group will be injected Triamcinolone Acetonide 4 mg/0.1ml. All subjects in this group will get Triamcinolone Acetonide 1mg/0.025 ml intravitreal injection just after the operation.
Interventions
A week before 25-gauge vitrectomy, all subjects in Ranibizumab group will receive Ranibizumab 0.5mg/0.05 ml intravitreal injection. All subjects in Ranibizumab group will get Ranibizumab 0.2 mg/0.02 ml intravitreal injection just after the operation.
A week before 25-gauge vitrectomy, all subjects in TA group will receive Triamcinolone Acetonide 4mg/0.1ml intravitreal injection. During operation all subjects in Ranibizumab group and in TA group will be injected Triamcinolone Acetonide 4 mg/0.1ml. All subjects in TA group will get Triamcinolone Acetonide 1mg/0.025 ml intravitreal injection just after the operation.
Eligibility Criteria
You may qualify if:
- Type II diabetes mellitus with Diabetic Retinopathy
- Vitreous hemorrhage/Proliferation of retinal/Tractional detachment of retina
You may not qualify if:
- Fasting blood-glucose more than 8mmol/ml
- 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
- JUNYAN ZHANGlead
- The First People's Hospital of Xuzhoucollaborator
Study Sites (1)
The First People Hospital of Xuzhou
Xuzhou, Jiangsu, 221002, China
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: 20332654RESULTDehghan 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: 22737351RESULTCho 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: 22848140RESULTSong 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: 17804919RESULTGupta 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: 24339677RESULTShamsi 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: 24379924RESULTRomero-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: 21860693RESULTBainbridge J. Refractory diabetic macular edema. J Ophthalmic Vis Res. 2010 Jul;5(3):143-4. No abstract available.
PMID: 22737347RESULTJahn 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: 15564755RESULTRobaszkiewicz 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: 20572497RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
SUYAN LI, MD
Ophthalmology Department of the 1st People Hospital of Xuzhou
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Senior Consultant and Statistician
Study Record Dates
First Submitted
May 14, 2015
First Posted
May 18, 2015
Study Start
June 1, 2015
Primary Completion
December 1, 2020
Study Completion
December 1, 2021
Last Updated
September 24, 2018
Record last verified: 2018-09