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.
4.1.1 Inclusion Criteria 4.1.1.1 General Inclusion Criteria
Signed Informed Consent
Ability to comply with the study protocol
History of diabetic eye disease
1.1.1 Exclusion Criteria
1. No more than 8 eyes with previous PRP can be enrolled. Previous PRP will be excluded once this cap of 8 eyes is met.
2. TRD involving or threatening the macula
3. Intraoperative or preoperative identification of previous peripheral PRP/Cryo for PDR ( only after cap of 8 eyes met per exclusion criteria #1)., TRD involving or threatening the macula, need for oil or gas
Single group
PDS Implant filled with 100 mg/mL Ranibizumab
DeviceIn 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
Ranibizumab
DrugThe 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.
PROPORTION OF PATIENTS WITHOUT COMPLICATIONS OF DIABETIC RETINOPATHY AT 9 MONTHS
Proportion of patients with \<500 PRP laser spots and without the occurrence of new incidence of diabetic macular edema or diabetic retinopathy-related vitreous hemorrhage, pre-retinal hemorrhage, tractional retinal detachment or anterior segment neovascularization from Study Day 1 through Study Day 252 (Month 9).
CHANGE IN VISION OVER 12 MONTHS
Mean change in Best Corrected Visual Acuity (BCVA) over 12 months visual acuity
NEED FOR SUPPLEMENTAL TREATMENT OVER 12 MONTH PERIOD
Proportion of patients needing supplemental injections, or PRP or vitrectomy over 12 months
VISUAL FIELD CHANGES FROM MONTH 3 TO MONTH 12
Mean Change in Humphfrey Visual Filed Score change from postoperative month 3 to month 12
CHANGE IN RETINAL NONPERFUSION AND LEAKAGE OVER 12 MONTHS
Change from baseline in area of retinal nonperfusion and macular leakage through 12 months, assessed with ultrawide-field fluorescein angiography by an independent reading center.
NUMBER OF INCIDENTS OF OCULAR ADVERSE EVENTS OVER 12 MONTHS
Proportion of participants with the following ocular adverse events of interest from study day 1 over 12 months: Endophthalmitis Rhegmatogenous retinal detachment (RRD) Progressed or new TRD Cataract Progression Conjunctival retraction /erosion/bleb/thickening Septum dislodgement Implant dislocation Conjunctival thickening/bleb Inability to refill/exchange due to conjunctival thickening/bleb VH secondary to PDS implant site bleeding intraoperatively Need for implant removal Need for exchange with PDS reimplantation Cataract progression requiring cataract surgery
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Southeast Retina Center, Georgia
Lead sponsor
Genentech, Inc.
Collaborator
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