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Completed

NCT Number: NCT02816710

Conbercept Injection in Treatment of Severe Proliferative Diabetic Retinopathy

To evaluate efficacy of different intravitreal Conbercept injection therapy in the treatment of severe proliferative diabetic retinopathy.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ruijin Hospital

Shanghai, Shanghai Municipality, 20025, China

About this study

To assess the clinical effects of preoperative, intraoperative or preoperative combined with intraoperative intravitreal conbercept (IVC) injection in pars plana vitrectomy (PPV) with silicone oil tamponade for severe proliferative diabetic retinopathy (PDR). Methods. These patients were randomly assigned to three groups: Group 1 received an IVC injection 3 to 5 days before surgery; Group 2 received an IVC injection at the end of surgery; and Group 3 received an IVC injection 3 to 5 days before PPV as well as an IVC injection at the end of PPV. Follow-up examinations were performed for at least six months after surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects of either sex aged ≥ 18 years.
  • Diagnosis of diabetes mellitus (type 1 or type 2);
  • Active proliferative diabetic retinopathy was clinically evident;
  • Study eyes required a vitrectomy and silicone oil tamponade due to vitreous hemorrhage with significant fibrous proliferation, tractional retinal detachment in the posterior pole or complicated retinal detachment, which can be detected by B-scan ultrasonography.
  • Ability to give informed consent.

Exclusion criteria

  • Coexistent ocular disease that may interfere with visual outcome;
  • Prior vitreoretinal surgery or anti-vascular endothelial growth factor (VEGF) pharmacotherapy in either eye;
  • A macula-involving retinal detachment for >6 months in the study eye;
  • Iris or angle neovascularization and neovascular glaucoma;
  • known allergy to any components of conbercept formulation
  • severe external ocular infection;
  • pregnancy or current oral contraceptive intake;
  • usage of anticoagulant or antiplatelet therapy;
  • preoperative or postoperative poor diabetes control [serum hemoglobin A1c (HbA1c) >11.0%];
  • uncontrolled systemic diseases, such as hypertension, cardiac diseases or presenting abnormal coagulation-associated blood diseases;
  • <6 months of follow-up post initial surgery.

Treatment and study plan

Conbercept

Drug

Conbercept is a humanized soluble fusion protein which has a high binding affinity to the Fc region of human immunoglobulin G1 simultaneously. Prior clinical studies have demonstrated that intravitreal conbercept (IVC) inhibits the process of angiogenesis in vivo and in vitro, and has been recognized as a novel effective treatment strategy for neovascularization, providing an alternative treatment option for ophthalmologists.

Primary outcomes

  1. Best-corrected Visual Acuity

    Time frame: 6 months

  2. Duration of Surgery

    Time frame: during the operation time

    To evaluate the influence of these three methods to the final duration of surgery. We carefully estimated the time of the vitrectomy from insertion to extraction of the 23-gauge three-port trocars.

  3. Intraoperative Bleeding

    Time frame: Time between the insertion and extraction of three 23-gauge vitrectomy ports

    The grading criteria for intraoperative bleeding: Grade 1, spontaneous cessation of minor bleeding or bleeding that stopped by transient elevation of perfusion pressure; Grade 2, moderate bleeding requiring endodiathermy or broad blood clots formed far away from the bleeding site; Grade 3, thick blood clots exceeding half of the posterior pole or affecting the operation field.

Secondary outcomes

  1. Postoperative Preretinal Blood

    Time frame: postoperatively, up to 1 week

    The grading criteria for postoperative preretinal blood: Grade 1, isolated blood clots within 10 disk area but without covering the posterior pole; Grade 2, broad blood clots exceeding 10 disk area regardless of involvement of the posterior pole; Grade 3, broad blood clots exceeding 10 disk area as well as involving the posterior pole. Maximal extent of preretinal blood within 1 week postoperatively was used for grading the extent of hemorrhage.

  2. Reabsorption Time of Blood

    Time frame: follow up period, up to an average of 6 months after the operation

    To monitor the reabsorption time of preretinal blood.

  3. Recurrent Vitreous Hemorrhage

    Time frame: follow up period, up to an average of 6 months after the operation

    Recurrent vitreous hemorrhage(VH) was referred to any new episode of VH occurring after one week postoperatively, dividing into early stage (≤ 4 weeks) and late stage (> 4 weeks).

  4. Frequency of Intraoperative Electrocoagulation

    Time frame: during the operation time

    The number of times electrocoagulation, which was used to stop bleeding, was carefully counted.

  5. Number of Participants With Neovascular Glaucoma (NVG)

    Time frame: follow up period, up to an average of 6 months after the operation

  6. Recurrent Retinal Detachment

    Time frame: follow up period, up to an average of 6 months after the operation

  7. Need for Reoperation

    Time frame: follow up period, up to an average of 6 months after the operation

    due to recurrent retinal detachment or unclear vitreous hemorrhage

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

Different Conbercept Injection Methods in Treatment of Severe Proliferative Diabetic Retinopathy

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 28, 2016
Registry last updated
Nov 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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