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Proliferative Diabetic RetinopathyPhase 2/3RaTAPDRNCT02328118

25-Gauge Vitrectomy With Ranibizumab or Triamcinolone Acetonide on Proliferative Diabetic Retinopathy in China

A Phase 2/3 study testing Ranibizumab and Triamcinolone Acetonide in people with Proliferative Diabetic Retinopathy, run by JUNYAN ZHANG at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Proliferative Diabetic Retinopathy
What is being tested?
Ranibizumab and Triamcinolone Acetonide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteChina
Study dates
Feb 2015to May 2017
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

SUYAN LI, Doctor contact

+86-13852101175

lisuyan1226@126.com

JUNYAN ZHANG, bachelor contact

+86-13701739364

richard.zhang@both-win.net

China1 site, 1 recruiting

  • The First People Hospital of Xuzhou

    Xuzhou, Jiangsu, 221002

    Suyan Li, Doctor, +86-13852101775, lisuyan1226@126.com

    Junyan Zhang, Bachelor, +86-13701739364, richard.zhang@both-win.net

    Recruiting

Other trials in China

About this study

Official title: 25-Gauge Vitrectomy Combine With Ranibizumab or Triamcinolone Acetonide on Proliferative Diabetic Retinopathy in Chinese Patients

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.

Read the detailed description

Proliferative diabetic retinopathy(PDR) is the leading cause of visual loss in diabetic patients. The operation indication includes non-absorbed vitreous haemorrhage, dense bleeding in front of the macular, proliferative vitreoretinopathy traction macular, tractional retinal detachment combined break, severe progressive fiber vascular proliferation and vitreous haemorrhage combined with early iris neovascularization.

Due to VEGF levels rise in vitreous cavity of PDR patients, some inflammatory cytokines involved in, make easy bleeding during surgery and heavier inflammatory reaction postoperation,thus affecting the curative effect of the operation.

Ranibizumab as angiogenesis inhibitors, has widely applied in the treatment of age-related macular degeneration, won the recognition of ophthalmologists.

Some scholars try to expand the application in diabetic macular edema, also obtained the good curative effect.Some scholars also applied the angiogenesis inhibitors to the diabetes retinopathy before surgery in the hope to reduce the occurrence of intraoperative bleeding.Compared with bevacizumab, the short half-life of lucentis, and thus reduce the inhibition of VEGF system risk.

In this project, the investigators will inject lucentis into vitreous cavity before surgery of PDR, and observe the effect and complications of the operation, compared with triamcinolone acetonide group(the control group); At the same time the cytokines level of VEGF, pigment epithelium-derived factor (PEDF), epidermal growth factor (EGF), Transforming Growth Factor-beta (TGF-beta), interleukin 6 (IL - 6) and interleukin 8 (IL - 8) will be detected before and after pretreatment with lucentis or triamcinolone acetonide, and the cytokines concentration change will be compared between two groups, the mechanism of PDR will be further clarified and theoretical basis for looking for treatment strategies will be laid.

Being tested
Ranibizumab, Triamcinolone Acetonide
Keywords
Lucentis, Ranibizumab, Triamcinolone Acetonide, Vitrectomy, PDR

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RanibizumabDrug

    Also called Lucentis, rhuFab V2

    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.

  • Triamcinolone AcetonideDrug

    Also called Vitreal S, Cinonide, Tricort 40, Kenalog

    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.

Study groups in NCT02328118
Study groupRoleWhat they receive
Ranibizumab 0.5 mgExperimentalAll subjects in this group will receive Ranibizumab (0.5mg/0.05ml) intravitreal injection.
Receives: Drug: Ranibizumab; Drug: Triamcinolone Acetonide
Triamcinolone Acetonide 4mgExperimentalAll patients in this group will receive Triamcinolone Acetonide(4mg/0.1ml) during operation.
Receives: Drug: Triamcinolone Acetonide

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 12 months after the last subject accepts vitrectomy

Secondary outcomes (2)

  1. the change of Best-corrected visual acuity

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

  2. the change of inflammatory factors in vitreous body

    Compare the change of inflammatory factors in vitreous chamber between two groups. These inflammatory factors including VEGF/PEDF,EGF/TGF-beta, IL-6 and IL-8. This is only focus before vitrectomy

    Measured: 7 days after injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2014 (estimated)
  2. Study startFeb 2015
  3. Primary completionMar 2017 (estimated)
  4. Study completionMay 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02328118
Sponsor's protocol ID
PDR-RAN-LSY
Acronym
RaTAPDR
Status last verified
Aug 2016
First submitted
20 Dec 2014
Last updated
25 Aug 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 20332654

  • 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.

    PubMed 22737351

  • 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.

    PubMed 22848140

  • 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.

    PubMed 17804919

  • 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.

    PubMed 24339677

  • 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.

    PubMed 24379924

  • 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.

    PubMed 21860693

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

    PubMed 22737347

  • 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.

    PubMed 15564755

  • 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.

    PubMed 20572497

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Ranibizumab and Triamcinolone Acetonide in people with Proliferative Diabetic Retinopathy, run by JUNYAN ZHANG at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact SUYAN LI, Doctor (+86-13852101175, lisuyan1226@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

composite outcome including amotio retinae,vitreous hemorrhage within 12 months after vitrectomy (time frame: 12 months after the last subject accepts vitrectomy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02328118, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2016.

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