Continuous Delivery of Ranibizumab Via the Port Delivery System for Proliferative Diabetic Retinopathy-related Vitreous Hemorrhage With Pars Plana Vitrectomy and Limited PRP.

Summary

In Prolifertive Diabetic Retinopathy eyes with bleeding known as vitreous hemorrhage (VH) requiring a surgical procedure to remove the vitreous, called a vitrectomy, we will determine if the benefit and safety of adding a small implant that will be filled with medication called Susvimo is better with limited laser treatment.

Description

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Device
  PDS Implant filled with 100 mg/mL Ranibizumab

  In PDR eyes with vitreous hemorrhage (VH) requiring vitrectomy, we propose to determine the safety and efficacy of adding the port delivery system (PDS) ranibizumab implant while omitting standard PRP endolaser but with the option to retain limited peripheral endolaser PRP based on surgeon discretion

• Drug
  Ranibizumab

  The dose of ranbizumab (100mg/ml) will be identical to the FDA approved dose for treatment of nAMD and DME/DR. The schedule for refill/exchange injection will be identical to that used in the PAGODA study (q6mos refill/exchange) for DME eyes and will be identical to that used in the PAVILLION study (q9mos refill/exchange) for eyes without DME.

Location