NCT01813773

Treatment With Intravitreal Aflibercept Injection For Proliferative Diabetic Retinopathy, The A.C.T Study

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Ophthalmic Consultants of Long Island · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety of intravitreal aflibercept injection in the treatment of proliferative diabetic retinopathy (PDR) by evaluating the incidence and severity of adverse events.

Detailed description

* Single center, open label pilot study using 2.0mg intravitreal aflibercept injection. (IAI) * 20 subjects with active PDR to be randomized into 2 groups, i.e. groups A and B. * Subjects in both arms will be followed-up every 4 weeks until week 52. * The primary endpoint of the study will be at week 52.

Conditions

• Proliferative Diabetic Retinopathy

Interventions

Type	Name	Description
DRUG	Intravitreal Aflibercept Injection (IAI)	EYLEA (aflibercept) is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration. Aflibercept is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa. Aflibercept is produced in recombinant Chinese hamster ovary (CHO) cells.

Timeline

• Start date: 2013-03-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2013-03-19
• Last updated: 2016-06-06

Locations

1 site across 1 country: United States