NCT03594461

Intense Treatment Regimen With Intravitreal Aflibercept Injection

Intense Treatment Regimen With Intravitreal Aflibercept Injection for Refractory Neovascular Age-Related Macular Degeneration With or Without Polypoidal Choroidal Vasculopathy

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Vitreous -Retina- Macula Consultants of New York · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety and efficacy of intense dosing for a limited period in patients who demonstrate refractory disease on monthly IAI. Patients will be followed for 52 weeks

Detailed description

The development of biologic therapy targeting VEGF has been revolutionary and has lowered the rate of functional blindness in many developed countries. Modalities to treat nvAMD have been based on monthly dosing. For many patients, this modality is adequate and they can achieve a dry macula. A subset of patients can even have their treatment intervals extended. There is, however, a subset of patients with recalcitrant neovascularization for whom IAI fails to produce a dry macula even with q4w dosing. An intense dosing schedule for a short period of time could decrease fluid activity in these patients.

Conditions

• Neovascular Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Aflibercept Injection	Intense Treatment Regimen for Refractory Neovascular Age-Related Macular Degeneration with or without Polypoidal Choroidal Vasculopathy

Timeline

• Start date: 2018-09-11
• Primary completion: 2020-03-01
• Completion: 2020-06-01
• First posted: 2018-07-20
• Last updated: 2019-01-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study