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Proliferative Diabetic RetinopathyPhase 44 PORTNCT07864480

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

A Phase 4 study testing PDS Implant filled with 100 mg/mL Ranibizumab and Ranibizumab in people with Proliferative Diabetic Retinopathy and Diabetic Retinopathy, run by Southeast Retina Center, Georgia at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PDS Implant filled with 100 mg/mL Ranibizumab and Ranibizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
Sep 2026to Dec 2029
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 14Show fewer
  • 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

Who cannot join

  • 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
  • 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).
Show all 73Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site
  • Southeast Retina Center

    Augusta, Georgia, 30909

    Jordany Zamor, BS. Biology, 706-650-0061, jzamor@southeastretina.com

    Sahara Rachman, 706-650-0061, srachman@southeastretina.com

Other trials in United States

About this study

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.

Read the detailed description

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.

Being tested
PDS Implant filled with 100 mg/mL Ranibizumab, Ranibizumab
Keywords
Diabetic Retinopathy, Port Delivery System, Vitrectomy, Proliferative Diabetic Retinopathy
Medical subject headings
Diabetic Retinopathy, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PDS Implant filled with 100 mg/mL RanibizumabDevice

    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

  • RanibizumabDrug

    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 groups in NCT07864480
Study groupRoleWhat they receive
Open LabelExperimentalOpen-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.
Receives: Device: PDS Implant filled with 100 mg/mL Ranibizumab; Drug: Ranibizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 9 months

Secondary outcomes (3)
  1. Change in Vision Over 12 Months

    Mean change in Best Corrected Visual Acuity (BCVA) over 12 months visual acuity

    Measured: 12 months

  2. Need for Supplemental Treatment Over 12 Month Period

    Proportion of patients needing supplemental injections, or PRP or vitrectomy over 12 months

    Measured: 12 Months

  3. Visual FIield Changes from Month 3 to Month 12

    Mean Change in Humphfrey Visual Filed Score change from postoperative month 3 to month 12

    Measured: 9 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionSep 2029 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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 . Intraoperative evaluation during PPV by the investigator surgeon will determine if the eye meets inclusion/exclusion criteria for enrollment or not. Twenty eyes meeting enrollment criteria will receive PDS implantation and no or limited PRP endolaser. As PDR-related VH frequently occurs in eyes with previous PRP, a maximum of 8 eyes with prior PRP will be included. Limited endolaser (no greater than 300 spots) will be applied to the superotemporal quadrant, for primarily mechanical support. Additional limited (no greater than 500 spots) endolaser PRP to the other quadrants may be applied to the retinal periphery (at or anterior to the equator).
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07864480
Sponsor's protocol ID
ML46392
Other IDs
ML46392
Acronym
4 PORT
Status last verified
Oct 2026
First submitted
20 Jul 2026
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No: The analysis population for the efficacy analyses will consist of all of the enrolled 20 eyes. Rates of primary and secondary outcomes will be compiled, analyzed and reported as a case series for publication. Analyses of primary and secondary outcomes for the subgroups of patients with and without prior PRP will be examined. Missed data will not be carried forward. Analyses at the specific time points will occur only for eyes with data at that time point.

Publications

  • Centers for Disease Control and Prevention (CDC). State-specific incidence of diabetes among adults--participating states, 1995-1997 and 2005-2007. MMWR Morb Mortal Wkly Rep. 2008 Oct 31;57(43):1169-73.

    PubMed 18971918
  • International Diabetes Federation: Facts and figures. Accessed 26 September 2016, 1612-1613

  • Varma R, Bressler NM, Doan QV, Gleeson M, Danese M, Bower JK, Selvin E, Dolan C, Fine J, Colman S, Turpcu A. Prevalence of and risk factors for diabetic macular edema in the United States. JAMA Ophthalmol. 2014 Nov;132(11):1334-40. doi: 10.1001/jamaophthalmol.2014.2854.

    PubMed 25125075
  • Antonetti DA, Klein R, Gardner TW. Diabetic retinopathy. N Engl J Med. 2012 Mar 29;366(13):1227-39. doi: 10.1056/NEJMra1005073. No abstract available.

    PubMed 22455417
  • Aiello LP. Angiogenic pathways in diabetic retinopathy. N Engl J Med. 2005 Aug 25;353(8):839-41. doi: 10.1056/NEJMe058142. No abstract available.

    PubMed 16120866
  • Klein R, Klein BE, Moss SE. A population-based study of diabetic retinopathy in insulin-using patients diagnosed before 30 years of age. Diabetes Care. 1985 Sep-Oct;8 Suppl 1:71-6. doi: 10.2337/diacare.8.1.s71.

    PubMed 4053957
  • Sivaprasad S, Prevost AT, Vasconcelos JC, Riddell A, Murphy C, Kelly J, Bainbridge J, Tudor-Edwards R, Hopkins D, Hykin P; CLARITY Study Group. Clinical efficacy of intravitreal aflibercept versus panretinal photocoagulation for best corrected visual acuity in patients with proliferative diabetic retinopathy at 52 weeks (CLARITY): a multicentre, single-blinded, randomised, controlled, phase 2b, non-inferiority trial. Lancet. 2017 Jun 3;389(10085):2193-2203. doi: 10.1016/S0140-6736(17)31193-5. Epub 2017 May 7.

    PubMed 28494920
  • Gross JG, Glassman AR, Liu D, Sun JK, Antoszyk AN, Baker CW, Bressler NM, Elman MJ, Ferris FL 3rd, Gardner TW, Jampol LM, Martin DF, Melia M, Stockdale CR, Beck RW; Diabetic Retinopathy Clinical Research Network. Five-Year Outcomes of Panretinal Photocoagulation vs Intravitreous Ranibizumab for Proliferative Diabetic Retinopathy: A Randomized Clinical Trial. JAMA Ophthalmol. 2018 Oct 1;136(10):1138-1148. doi: 10.1001/jamaophthalmol.2018.3255.

    PubMed 30043039
  • Writing Committee for the Diabetic Retinopathy Clinical Research Network; Gross JG, Glassman AR, Jampol LM, Inusah S, Aiello LP, Antoszyk AN, Baker CW, Berger BB, Bressler NM, Browning D, Elman MJ, Ferris FL 3rd, Friedman SM, Marcus DM, Melia M, Stockdale CR, Sun JK, Beck RW. Panretinal Photocoagulation vs Intravitreous Ranibizumab for Proliferative Diabetic Retinopathy: A Randomized Clinical Trial. JAMA. 2015 Nov 24;314(20):2137-2146. doi: 10.1001/jama.2015.15217.

    PubMed 26565927
  • Obeid A, Su D, Patel SN, Uhr JH, Borkar D, Gao X, Fineman MS, Regillo CD, Maguire JI, Garg SJ, Hsu J. Outcomes of Eyes Lost to Follow-up with Proliferative Diabetic Retinopathy That Received Panretinal Photocoagulation versus Intravitreal Anti-Vascular Endothelial Growth Factor. Ophthalmology. 2019 Mar;126(3):407-413. doi: 10.1016/j.ophtha.2018.07.027. Epub 2018 Aug 2.

    PubMed 30077614
  • Antoszyk AN, Glassman AR, Beaulieu WT, Jampol LM, Jhaveri CD, Punjabi OS, Salehi-Had H, Wells JA 3rd, Maguire MG, Stockdale CR, Martin DF, Sun JK; DRCR Retina Network. Effect of Intravitreous Aflibercept vs Vitrectomy With Panretinal Photocoagulation on Visual Acuity in Patients With Vitreous Hemorrhage From Proliferative Diabetic Retinopathy: A Randomized Clinical Trial. JAMA. 2020 Dec 15;324(23):2383-2395. doi: 10.1001/jama.2020.23027.

    PubMed 33320223
  • Pieramici DJ, Awh CC, Chang M, Emanuelli A, Holekamp NM, Hu AY, Suner IJ, Wykoff CC, Brittain C, Howard D, Quezada-Ruiz C, Santhanakrishnan A, Latkany P. Port Delivery System With Ranibizumab vs Monitoring in Nonproliferative Diabetic Retinopathy Without Macular Edema: The Pavilion Randomized Clinical Trial. JAMA Ophthalmol. 2025 Apr 1;143(4):317-325. doi: 10.1001/jamaophthalmol.2025.0001.

    PubMed 40048178
  • Khanani AM, Campochiaro PA, Graff JM, Marcus DM, Miller D, Mittra RA, Regillo C, Sheth VS, Bobbala A, Gune S, Lin S, Quezada-Ruiz C, Malhotra V. Continuous Ranibizumab via Port Delivery System vs Monthly Ranibizumab for Treatment of Diabetic Macular Edema: The Pagoda Randomized Clinical Trial. JAMA Ophthalmol. 2025 Apr 1;143(4):326-335. doi: 10.1001/jamaophthalmol.2025.0006.

    PubMed 40048197
  • Early vitrectomy for severe vitreous hemorrhage in diabetic retinopathy. Two-year results of a randomized trial. Diabetic Retinopathy Vitrectomy Study report 2. The Diabetic Retinopathy Vitrectomy Study Research Group. Arch Ophthalmol. 1985 Nov;103(11):1644-52.

    PubMed 2865943
  • Ho T, Smiddy WE, Flynn HW Jr. Vitrectomy in the management of diabetic eye disease. Surv Ophthalmol. 1992 Nov-Dec;37(3):190-202. doi: 10.1016/0039-6257(92)90137-i.

    PubMed 1475753

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing PDS Implant filled with 100 mg/mL Ranibizumab and Ranibizumab in people with Proliferative Diabetic Retinopathy and Diabetic Retinopathy, run by Southeast Retina Center, Georgia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 73 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sahara Rachman (706-650-0061, srachman@southeastretina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Patients Without Complications of Diabetic Retinopathy at 9 Months (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07864480, which also lists 37 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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