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

Part of paid clinical trials in Augusta, Georgia.

Sponsor
Southeast Retina Center, Georgia
Study ID
NCT07864480
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PDS Implant filled with 100 mg/mL Ranibizumab — DEVICE
    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
  • Ranibizumab — DRUG
    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.

Study Details

In prolifertive diabetic retinopathy (PDR) 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.

Key Dates

First listed
Oct 7, 2026
Start date
Sep 30, 2026
Status verified
Oct 2026
Primary completion
Sep 30, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Open Label
    Open-labeled, non-randomized, single-arm surgical case series will enroll 20 PDR eyes with VH requiring (determined by investigator prior to baseline/screening visit) PPV and will evaluate the safety and efficacy of adding PDS with ranibizumab (100 mg/ml) during vitrectomy without or with limited intraoperative PRP endolaser.

Primary Outcome Measure

Proportion of Patients Without Complications of Diabetic Retinopathy at 9 Months [ Time Frame: 9 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Southeast Retina CenterAugustaGeorgia30909
Jordany Zamor, BS. Biology
[email protected]
706-650-0061
Sahara Rachman
[email protected]
706-650-0061
Dennis Marcus, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Augusta, GA

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By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Southeast Retina Center· Augusta, GA

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