Day Regimes of CONbercept on CytokinEs of PDR Patients Undergoing Vitrectomy - Trial (CONCEPT)

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Apr 12, 2018

Keywords

ClinConnect Summary

Proliferative diabetic retinopathy (PDR), characterized by neovascularization and fibrous proliferation, is a severe and common complication of diabetes mellitus (DM). Persistent vitreous hemorrhage (VH) caused by neovascularization and tractional retinal detachment (TRD) caused by fibrous proliferation can lead to permanent vision loss or even blindness, which are the most common indications for surgical intervention.

As neovascularization is the basal pathophysiological change of PDR and vascular endothelial growth factor (VEGF) has been acknowledged as primary angiogenesis factor, the pre...

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Eligibility criteria

• Inclusion Criteria:
• • 18 years or older
• • Type 1 or 2 diabetes
• • PDR patients requiring surgical intervention for complications of vitreous hemorrhage or traction retinal detachment and pre-operative IVC treatment.
• • women postmenopausal for 12 months before the study, surgically sterile, or not pregnant and on effective contraception.
• Exclusion Criteria:
• • previous retinal vein occlusion.
• • any intraocular surgery within the previous 12 months.
• • myopia of \> or = to 8 diopters.
• • active ocular or periocular infection
• • treatment with an investigational agent for any condition 60 days prior to enrollment.
• • evidence of severe cardiac disease.
• • clinically significant peripheral vascular disease (previous surgery, amputation, or symptoms of claudication)
• • uncontrolled hypertension (treated systolic blood pressure \> 155 mmHg or diastolic blood pressure \> 95 mmHg)
• • stroke within the preceding 12 months.