| Registry | NCT07864480, acronym 4 PORT |
|---|---|
| Status | Not yet recruiting |
| Phase | Phase 4 |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 20 (Estimated) |
| Sponsor | Southeast Retina Center, Georgia (Other); collaborators: Genentech, Inc. |
| Conditions | Proliferative Diabetic Retinopathy, Diabetic Retinopathy, Diabetes |
| Interventions | PDS Implant filled with 100 mg/mL Ranibizumab, Ranibizumab (Device, drug) |
| Dates | start 2026-09-01 (estimated), primary completion 2029-09-01 (estimated), completion 2029-12-01 (estimated), first posted 2026-10-07, last updated 2026-10-13 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Proliferative Diabetic Retinopathy All trials for Diabetic Retinopathy All trials of PDS Implant filled with 100 mg/mL Ranibizumab All trials of Ranibizumab
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Open Label | Experimental | Device: PDS Implant filled with 100 mg/mL Ranibizumab; Drug: Ranibizumab | 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. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * 4.1.1 Inclusion Criteria 4.1.1.1 General Inclusion Criteria Patients must meet the following general inclusion criteria (for study entry): * Signed Informed Consent * Ability to comply with the study protocol * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, as defined below: Women must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for at least 28 days after the last intravitreal injection of ranibizumab or 1 year after the last implant refill exchange of ranibizumab. A woman is considered to be of childbearing potential if she is post-menarchal, has not reached a postmenopausal state ( Greater than or equal to, 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements. Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. 4.1.1.2 Ocular Inclusion Criteria * History of diabetic eye disease * PDR-related VH requiring PPV per investigator discretion prior to preoperative visit. * BCVA LP or better * Treatment with at least 2 anti-VEGF injections prior to study day 1 Exclusion Criteria: * 1.1.1 Exclusion Criteria * 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 * 4\. Neovascular glaucoma and/or anterior segment neovascularization * 5\. Rhegmatogenous Retinal Detachment (RRD) (current as well as history of). (Previously treated tears with laser/cryo or current intraoperative tears treated with focal endolaser/cryo are allowed per investigator discretion; need for gas or oil are excluded). * 6\. History of PPV or Scleral Buckle or Treatment of RRD * 7\. Pregnancy or potential for pregnancy * 8\. Extensive preretinal fibrosis requiring dissection and need for standard (requiring PRP posterior to equator) endolaser PRP or gas or oil. (If mild fibrosis that is easily dissected then such an eye could be included per investigator's discretion) 1.1.1.1 Prior Ocular Treatment Patients who meet any of the following prior ocular treatment exclusion criteria will be excluded from study entry: Study Eye * History of corneal transplant * History of conjunctival surgery in the superotemporal quadrant * Previous intraocular device implantation excluding intraocular lenses * History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery * Prior participation in a clinical trial involving intravitreal anti-VEGF agents not approved by the FDA on the day of screening * Intraocular laser therapy including selective laser trabeculoplasty, yttrium aluminum garnet (YAG), prophylactic peripheral iridotomy within 1 year of screening, or YAG capsulotomy within 2 months of screening * Contact lens wear within 1 months of screening * Any prior ocular penetrating trauma or blunt trauma deemded significant by the investigator * History of corneal transplantation, including partial-thickness corneal grafts (e.g., Descemet membrane endothelial keratoplasty, Descemet stripping endothelial keratoplasty) 1.1.1.2 VH Characteristics Patients who meet any of the following exclusion criteria related to VH characteristics will be excluded from study entry: Study Eye • VH secondary to causes other than PDR (ie. CRVO, BRVO, trauma, etc) 1.1.1.3 Concurrent Ocular Conditions Patients who meet any of the following exclusion criteria related to concurrent ocular conditions will be excluded from study entry: Study Eye * Retinal pigment epithelial tear, CNV, geographic atrophy secondary to AMD, macular scarring or ischemia limiting visual acuity to worse than 20/400, * Retinal tears or peripheral retinal breaks on depressed fundus examination * Previous violation of the posterior capsule is also an exclusion criterion unless it occurred as a result of YAG laser posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation * Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia or evidence of pathologic myopia on depressed fundus examination * Preoperative refractive error that exceeds 8 diopters of myopia, for patients who have undergone prior refractive or cataract surgery * Spherical equivalent of the refractive error demonstrating more than 5 diopters of hyperopia * Preoperative refractive error that exceeds 5 diopters of hyperopia, for patients who have undergone prior refractive or cataract surgery * Uncontrolled ocular hypertension or glaucoma (defined as intraocular pressure \[IOP\] > 25 mmHg or a cup-to-disc ratio > 0.8, despite treatment with antiglaucoma medication) and any such condition the investigator determines may require a glaucoma-filtering surgery during a patient's participation in the study * Scleral pathology in the superotemporal quadrant (e.g., scleral thinning or calcification) * Conjunctival pathologies (e.g., pterygium, scarring, thinning, fibrosis) in the superotemporal quadrant * History or presence of severe posterior blepharitis, recurrent chalazia or hordeolum, severe dry eye syndrome, or severe allergic conjunctivitis * Ectropion, entropion, or other impairment of the upper or lower eyelid impacting lid functionality needed to protect the ocular surface from exposure * Trichiasis * Corneal neuropathy * Lagophthalmos or incomplete blink * Active or history of facial nerve palsy/paresis * Aphakia or absence of the posterior capsule * Any concurrent intraocular condition (e.g., cataract, glaucoma, AMD,) that would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results * Any ocular condition suggestive of corneal disorder * Previous corneal endothelial cell damage, including from blunt or surgical trauma (including complicated cataract surgery resulting in complicated lens placement such as anterior chamber intraocular lens, sulcus intraocular lens, or aphakia) * Any active or history of uveitis (e.g., idiopathic, drug-associated or autoimmune associated) * Active or history of keratitis, scleritis, or endophthalmitis * Active ocular or periocular infection (i.e., conjunctivitis, dacryocystitis) * Active or history of Sjogren's syndrome or keratoconjunctivitis sicca * Active or history of floppy eyelid syndrome * Active or history of chronic eye rubbing * Active thyroid eye disease 1.1.1.4 Concurrent Systemic Conditions Patients who meet any of the following exclusion criteria related to concurrent systemic conditions will be excluded from study entry: * History of uncontrolled blood pressure (defined as systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 110 mmHg, while a patient is at rest) If the patient's blood pressure must be controlled by antihypertensive medication, the patient may become eligible if medication is taken continuously for at least 30 days prior to enrollment. * Active or history of autoimmune diseases, such as rheumatoid arthritis, lupus, granulomatosis with polyangiitis (Wegner's) * History of stroke within the last 3 months prior to screening * Uncontrolled atrial fibrillation within 3 months of screening * History of myocardial infarction within the last 3 months prior to screening * History of other disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the implant and that might affect interpretation of the results of the study or renders the patient at high risk of treatment complications, in the opinion of the investigator * Current active systemic infection * Use of any systemic anti-VEGF agents * Chronic use of oral corticosteroids (> 10 mg/day of prednisone or equivalent) * Active cancer within 12 months of enrollment except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score of £ 6 and a stable prostate-specific antigen for > 12 months * Previous participation in any non-ocular (systemic) disease studies of investigational drugs within 1 month prior to screening (excluding vitamins and minerals) * Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives of the screening visit * Requirement for continuous use of any medications or treatments indicated in Section 4.4.2, "Prohibited Therapy" * Pregnant or breastfeeding, or intention to become pregnant during the study * Women of childbearing potential must have a negative urine pregnancy test result within 28 days prior to initiation of study treatment. If the urine pregnancy test is positive, it must be confirmed by a serum pregnancy test. 1.2 METHOD OF TREATMENT ASSIGNMENT Open label with PDS ranibizumab (100mg/ml) with implant/exchange injection q6mos and q9mos for eyes with and without DME, respectively. Estimated 20 eyes enrolled and 30 eyes screened at rate of accrual of 20 eyes at 1 year and follow-up 1 year (2 years total duration of study)
| Facility | City | Country | Status |
|---|---|---|---|
| Southeast Retina Center | Augusta, Georgia | United States |