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

NCT07864480 | Not Yet Recruiting Phase 4 FDA Drug FDA Device

• 1 other identifier: ML46392
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 laser treatment.

Conditions

Proliferative Diabetic Retinopathy; Diabetic Retinopathy; Diabetes

Keywords

Diabetic Retinopathy; Port Delivery System; Vitrectomy; Proliferative Diabetic Retinopathy

Outcome Measures

Primary Outcomes (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).

  9 months

Secondary Outcomes (3)

• Change in Vision Over 12 Months

  12 months

• Need for Supplemental Treatment Over 12 Month Period

  12 Months

• Visual FIield Changes from Month 3 to Month 12

  9 Months

Other Outcomes (2)

• Change in Retinal Nonperfusion and Leakage Over 12 Months

  12 months

• Number of Incidents of Ocular Adverse Events Over 12 Months

  12 months

Study Arms (1)

Open Label

EXPERIMENTAL

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.

Device: PDS Implant filled with 100 mg/mL Ranibizumab; Drug: Ranibizumab

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

Open Label

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.

Open Label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• \. No more than 8 eyes with previous PRP can be enrolled. Previous PRP will be excluded once this cap of 8 eyes is met.
• \. TRD involving or threatening the macula
• \. Neovascular glaucoma and/or anterior segment neovascularization
• \. 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).
• \. History of PPV or Scleral Buckle or Treatment of RRD
• \. Pregnancy or potential for pregnancy
• \. 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)
• Prior Ocular Treatment
• 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

Sponsors & Collaborators

• Southeast Retina Center, Georgia: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Southeast Retina Center

Augusta, Georgia, 30909, United States

Location

Related Publications (37)

• 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.

  PMID: 18971918 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 25125075 BACKGROUND

• 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.

  PMID: 22455417 BACKGROUND

• 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.

  PMID: 16120866 BACKGROUND

• 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.

  PMID: 4053957 BACKGROUND

• 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.

  PMID: 28494920 BACKGROUND

• 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.

  PMID: 30043039 BACKGROUND

• 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.

  PMID: 26565927 BACKGROUND

• 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.

  PMID: 30077614 BACKGROUND

• 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.

  PMID: 33320223 BACKGROUND

• 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.

  PMID: 40048178 BACKGROUND

• 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.

  PMID: 40048197 BACKGROUND

• 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.

  PMID: 2865943 BACKGROUND

• 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.

  PMID: 1475753 BACKGROUND

• El Annan J, Carvounis PE. Current management of vitreous hemorrhage due to proliferative diabetic retinopathy. Int Ophthalmol Clin. 2014 Spring;54(2):141-53. doi: 10.1097/IIO.0000000000000027.

  PMID: 24613890 BACKGROUND

• Wells JA, Glassman AR, Ayala AR, Jampol LM, Bressler NM, Bressler SB, Brucker AJ, Ferris FL, Hampton GR, Jhaveri C, Melia M, Beck RW; Diabetic Retinopathy Clinical Research Network. Aflibercept, Bevacizumab, or Ranibizumab for Diabetic Macular Edema: Two-Year Results from a Comparative Effectiveness Randomized Clinical Trial. Ophthalmology. 2016 Jun;123(6):1351-9. doi: 10.1016/j.ophtha.2016.02.022. Epub 2016 Feb 27.

  PMID: 26935357 BACKGROUND

• Diabetic Retinopathy Clinical Research Network; Wells JA, Glassman AR, Ayala AR, Jampol LM, Aiello LP, Antoszyk AN, Arnold-Bush B, Baker CW, Bressler NM, Browning DJ, Elman MJ, Ferris FL, Friedman SM, Melia M, Pieramici DJ, Sun JK, Beck RW. Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema. N Engl J Med. 2015 Mar 26;372(13):1193-203. doi: 10.1056/NEJMoa1414264. Epub 2015 Feb 18.

  PMID: 25692915 BACKGROUND

• Nguyen QD, Brown DM, Marcus DM, Boyer DS, Patel S, Feiner L, Gibson A, Sy J, Rundle AC, Hopkins JJ, Rubio RG, Ehrlich JS; RISE and RIDE Research Group. Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE. Ophthalmology. 2012 Apr;119(4):789-801. doi: 10.1016/j.ophtha.2011.12.039. Epub 2012 Feb 11.

  PMID: 22330964 BACKGROUND

• Heier JS, Korobelnik JF, Brown DM, Schmidt-Erfurth U, Do DV, Midena E, Boyer DS, Terasaki H, Kaiser PK, Marcus DM, Nguyen QD, Jaffe GJ, Slakter JS, Simader C, Soo Y, Schmelter T, Vitti R, Berliner AJ, Zeitz O, Metzig C, Holz FG. Intravitreal Aflibercept for Diabetic Macular Edema: 148-Week Results from the VISTA and VIVID Studies. Ophthalmology. 2016 Nov;123(11):2376-2385. doi: 10.1016/j.ophtha.2016.07.032. Epub 2016 Sep 17.

  PMID: 27651226 BACKGROUND

• Wong TY, Haskova Z, Asik K, Baumal CR, Csaky KG, Eter N, Ives JA, Jaffe GJ, Korobelnik JF, Lin H, Murata T, Ruamviboonsuk P, Schlottmann PG, Seres AI, Silverman D, Sun X, Tang Y, Wells JA, Yoon YH, Wykoff CC; YOSEMITE and RHINE Investigators. Faricimab Treat-and-Extend for Diabetic Macular Edema: Two-Year Results from the Randomized Phase 3 YOSEMITE and RHINE Trials. Ophthalmology. 2024 Jun;131(6):708-723. doi: 10.1016/j.ophtha.2023.12.026. Epub 2023 Dec 28.

  PMID: 38158159 BACKGROUND

• Bressler SB, Liu D, Glassman AR, Blodi BA, Castellarin AA, Jampol LM, Kaufman PL, Melia M, Singh H, Wells JA; Diabetic Retinopathy Clinical Research Network. Change in Diabetic Retinopathy Through 2 Years: Secondary Analysis of a Randomized Clinical Trial Comparing Aflibercept, Bevacizumab, and Ranibizumab. JAMA Ophthalmol. 2017 Jun 1;135(6):558-568. doi: 10.1001/jamaophthalmol.2017.0821.

  PMID: 28448655 BACKGROUND

• Figueira J, Fletcher E, Massin P, Silva R, Bandello F, Midena E, Varano M, Sivaprasad S, Eleftheriadis H, Menon G, Amaro M, Ayello Scheer S, Creuzot-Garcher C, Nascimento J, Alves D, Nunes S, Lobo C, Cunha-Vaz J; EVICR.net Study Group. Ranibizumab Plus Panretinal Photocoagulation versus Panretinal Photocoagulation Alone for High-Risk Proliferative Diabetic Retinopathy (PROTEUS Study). Ophthalmology. 2018 May;125(5):691-700. doi: 10.1016/j.ophtha.2017.12.008. Epub 2018 Feb 1.

  PMID: 29395119 BACKGROUND

• Diabetic Retinopathy Clinical Research Network*. Randomized clinical trial evaluating intravitreal ranibizumab or saline for vitreous hemorrhage from proliferative diabetic retinopathy. JAMA Ophthalmol. 2013 Mar;131(3):283-93. doi: 10.1001/jamaophthalmol.2013.2015.

  PMID: 23370902 BACKGROUND

• Marcus, D., Singh, H., Starnes, D., Walia, H., Farooq, A., & Frazier, H. et al. Endolaserless Vitrectomy With Intravitreal Aflibercept Injection for Proliferative Diabetic Retinopathy-Related Vitreous Hemorrhage (LASER LESS TRIAL). Journal Of Vitreoretinal Diseases 2018; 2(3), 127-137

  BACKGROUND

• D'Amico, D.. From the Editor-in-Chief. Journal Of Vitreoretinal Diseases 2018;2(3), 125-126.

  BACKGROUND

• Zhao XY, Xia S, Chen YX. Antivascular endothelial growth factor agents pretreatment before vitrectomy for complicated proliferative diabetic retinopathy: a meta-analysis of randomised controlled trials. Br J Ophthalmol. 2018 Aug;102(8):1077-1085. doi: 10.1136/bjophthalmol-2017-311344. Epub 2017 Dec 15.

  PMID: 29246890 BACKGROUND

• Maguire MG, Liu D, Glassman AR, Jampol LM, Johnson CA, Baker CW, Bressler NM, Gardner TW, Pieramici D, Stockdale CR, Sun JK; DRCR Retina Network. Visual Field Changes Over 5 Years in Patients Treated With Panretinal Photocoagulation or Ranibizumab for Proliferative Diabetic Retinopathy. JAMA Ophthalmol. 2020 Mar 1;138(3):285-293. doi: 10.1001/jamaophthalmol.2019.5939.

  PMID: 31999300 BACKGROUND

• Marcus D. Endolaserless Vitrectomy with Intravitreal Aflibercept Injection (IAI) for Proliferative Diabetic Retinopathy (PDR)-Related Vitreous Hemorrhage: 1 Year Results (LASER LESS TRIAL). Presented at the annual meeting of the American Society of Retina Specialists (ASRS). Vancouver, Canada, July, 2018.

  BACKGROUND

• Kasetty VM, Starnes DC, Sood N, Qin LG, Moses MM, Frazier HK, Singh H, Marcus DM. Complications, Compliance, and 3-Year Outcomes After Endolaserless Vitrectomy With Aflibercept Monotherapy for Proliferative Diabetic Retinopathy-Related Vitreous Hemorrhage. Ophthalmic Surg Lasers Imaging Retina. 2023 Feb;54(2):89-96. doi: 10.3928/23258160-20221216-02. Epub 2023 Feb 1.

  PMID: 36780633 BACKGROUND

• Levy R, Marcus DM. Complications, Compliance and 2 Year Outcomes after Endolaserless Vitrectomy with Aflibercept Monotherapy for PDR-Related Vitreous Hemorrhage. Presented virtually at the Association of Research in Vision and Ophthalmology (ARVO) meeting. May, 2020

  BACKGROUND

• Marcus DM, Taylor C, Starnes, D, et al. Ultra wide-field fluorescein angiographic-guided aflibercept (WFFAGA) monotherapy for proliferative diabetic retinopathy (PDR). J. Clin. Ophthalmol. 2019;3(2):197-204.

  BACKGROUND

• Wubben TJ, Johnson MW; Anti-VEGF Treatment Interruption Study Group. Anti-Vascular Endothelial Growth Factor Therapy for Diabetic Retinopathy: Consequences of Inadvertent Treatment Interruptions. Am J Ophthalmol. 2019 Aug;204:13-18. doi: 10.1016/j.ajo.2019.03.005. Epub 2019 Mar 13.

  PMID: 30878488 BACKGROUND

• Gao X, Obeid A, Aderman CM, Talcott KE, Ali FS, Adam MK, Rovner BW, Hyman L, Ho AC, Hsu J. Loss to Follow-up After Intravitreal Anti-Vascular Endothelial Growth Factor Injections in Patients with Diabetic Macular Edema. Ophthalmol Retina. 2019 Mar;3(3):230-236. doi: 10.1016/j.oret.2018.11.002. Epub 2018 Nov 10.

  PMID: 31014699 BACKGROUND

• Bressler SB, Beaulieu WT, Glassman AR, Gross JG, Melia M, Chen E, Pavlica MR, Jampol LM; Diabetic Retinopathy Clinical Research Network. Panretinal Photocoagulation Versus Ranibizumab for Proliferative Diabetic Retinopathy: Factors Associated with Vision and Edema Outcomes. Ophthalmology. 2018 Nov;125(11):1776-1783. doi: 10.1016/j.ophtha.2018.04.039. Epub 2018 Jul 3.

  PMID: 29980333 BACKGROUND

• Campochiaro PA, Marcus DM, Awh CC, Regillo C, Adamis AP, Bantseev V, Chiang Y, Ehrlich JS, Erickson S, Hanley WD, Horvath J, Maass KF, Singh N, Tang F, Barteselli G. The Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration: Results from the Randomized Phase 2 Ladder Clinical Trial. Ophthalmology. 2019 Aug;126(8):1141-1154. doi: 10.1016/j.ophtha.2019.03.036. Epub 2019 Apr 1.

  PMID: 30946888 BACKGROUND

• Holekamp NM, Campochiaro PA, Chang MA, Miller D, Pieramici D, Adamis AP, Brittain C, Evans E, Kaufman D, Maass KF, Patel S, Ranade S, Singh N, Barteselli G, Regillo C; all Archway Investigators. Archway Randomized Phase 3 Trial of the Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration. Ophthalmology. 2022 Mar;129(3):295-307. doi: 10.1016/j.ophtha.2021.09.016. Epub 2021 Sep 29.

  PMID: 34597713 BACKGROUND

MeSH Terms

Conditions

Diabetic Retinopathy; Diabetes Mellitus

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Dennis Marcus, MD

  Southeast Retina Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sahara Rachman

CONTACT

706-650-0061; srachman@southeastretina.com

Jordany Zamor

CONTACT

706-650-0061; jzamor@southeastretina.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: October 7, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: October 13, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)