Phase 4
N=112
Conbercept Injection in Treatment of Severe Proliferative Diabetic Retinopathy
Proliferative Diabetic Retinopathy · Tractional Retinal Detachment
Bottom Line
View on ClinicalTrials.gov: NCT02816710 ↗Enrolled (actual)
112
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Best-corrected Visual Acuity — 1.25; 1.29; 1.16 LogMAR
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Conbercept (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ruijin Hospital
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best-corrected Visual Acuity |
1.25; 1.29; 1.16 | — |
| PRIMARY Duration of Surgery |
55.41; 67.66; 57.86 | — |
| PRIMARY Intraoperative Bleeding |
15; 7; 12; 12; 16; 11 | — |
| SECONDARY Postoperative Preretinal Blood |
14; 15; 17; 11; 11; 8 | — |
| SECONDARY Reabsorption Time of Blood |
11.24; 12.23; 10.10 | — |
| SECONDARY Recurrent Vitreous Hemorrhage |
6; 7; 2; 5; 3; 2 | — |
| SECONDARY Frequency of Intraoperative Electrocoagulation |
1.73; 3.00; 1.34 | — |
| SECONDARY Number of Participants With Neovascular Glaucoma (NVG) |
4; 5; 2 | — |
| SECONDARY Recurrent Retinal Detachment |
4; 5; 3 | — |
| SECONDARY Need for Reoperation |
11; 9; 6 | — |
Summary
To evaluate efficacy of different intravitreal Conbercept injection therapy in the treatment of severe proliferative diabetic retinopathy.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02816710). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.