Prophylactic Effect of Conbercept Intravitreal Injection at the Conclusion

Status Not yet recruiting

Clinical Trial Summary

Diabetic macular edema (DME) is an important cause of central vision impairment among people with diabetic retinopathy (DR), which can have a significant adverse effect on daily activities and quality of life. Diabetic patients with preexisting DME are at increased risk of worsening edema following cataract surgery. Previous studies also reported progression of DR after cataract surgery. Clinically significant DME is now classified into center-involved DME (CI-DME) and non center-involved DME (non-CI DME). Randomized clinical trials have established intravitreal antivascular endothelial growth factor (VEGF) therapy as first-line treatment for visual impairment from CI-DME and studies have addressed the influence of anti-VEGF therapy among patients with DME undergoing cataract surgery. However, for patients with non-CI DME before cataract surgery, whether anti-VEGF therapy is necessary at the end of surgery to prevent CI-DME is still clinically controversial. In order to evaluate the prophylactic effect of Conbercept (a recombinant fusion protein with high affinity to all VEGF isoforms and PIGF) intravitreal injection at the conclusion of cataract surgery for DME in patients with DR, the investigators will prospectively recruit 40 cataract patients with DR and non-CI DME and randomly assign these subjects into the study group (combined cataract surgery and intravitreal Conbercept injection, 20 cases) and the control group (cataract surgery alone, 20 cases). The primary outcomes include mean changes in central retinal thickness (CRT) and in diabetic retinopathy severity score (DRSS). The secondary outcomes include changes in best corrected visual acuity (BCVA), foveal avascular zone (FAZ), retinal vessel density (VD), the aqueous concentrations of VEGF, PIGF, interleukin- (IL-) 2, IL-5, IL-6, and IL-8.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04668703
Study type	Interventional
Source	Eye & ENT Hospital of Fudan University
Contact	Jin Yang, MD, ph.D.
Phone	+8613671632525
Email	jin_er76@hotmail.com
Status	Not yet recruiting
Phase	N/A
Start date	January 1, 2021
Completion date	January 1, 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03660371` - ILM Peeling in PDR Patients Undergoing PPV for VH	N/A
Completed	`NCT03660384` - Silicone Oil Versus Gas in PDR Patients Undergoing Vitrectomy	N/A
Completed	`NCT03660345` - PPV With Internal Limiting Membrane Peeling for Treatment-Naïve DME	Phase 3
Completed	`NCT04905459` - ARDA Software for the Detection of mtmDR
Active, not recruiting	`NCT04271709` - Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT)	N/A
Recruiting	`NCT03713268` - Intraoperative OCT Guidance of Intraocular Surgery II
Completed	`NCT05022615` - Comparing 3 Imaging Systems
Completed	`NCT00385333` - Metabolic Mapping to Measure Retinal Metabolism	Phase 2
Recruiting	`NCT04101604` - Biomarkers of Common Eye Diseases
Completed	`NCT03702374` - Combined Antioxidant Therapy on Oxidative Stress, Mitochondrial Dysfunction Markers in Diabetic Retinopathy	Phase 3
Completed	`NCT01908816` - An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases.	Phase 3
Completed	`NCT04009980` - Long-term Retinal Changes After Topical Citicoline Administration in Patients With Mild Signs of Diabetic Retinopathy in Type 1 Diabetes Mellitus.	N/A
Completed	`NCT02924311` - Routine Clinical Practice for Use of Intravitreal Aflibercept Treatment in Patients With Diabetic Macular Edema
Not yet recruiting	`NCT06257082` - Video-based Patient Education Intervention for Diabetic Eye Screening in Latinx Communities	N/A
Not yet recruiting	`NCT05452993` - Screening for Diabetic Retinopathy in Pharmacies With Artificial Intelligence Enhanced Retinophotography	N/A
Withdrawn	`NCT02812030` - Aflibercept for Retinopathy in the Real World	N/A
Completed	`NCT02391558` - Clinical Evaluation of Noninvasive OCT Angiography Using a Zeiss OCT Prototype to Compare to Fluorescein Angiography	N/A
Active, not recruiting	`NCT02330042` - OCT Biomarkers for Diabetic Retinopathy
Active, not recruiting	`NCT02353923` - OcuStem Nutritional Supplement in Diabetic Patients With Mild to Moderate Non-proliferative Retinopathy	N/A
Completed	`NCT02390245` - Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Prophylactic Effect of Conbercept Intravitreal Injection at the Conclusion of Cataract Surgery for Diabetic Macular Edema

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms