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NCT Number: NCT07592273

Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema

Diabetic Retinopathy (DR) is a common eye condition caused by diabetes, where high blood sugar levels damage the blood vessels in the back part of the eye (called the retina). Over time, this damage can lead to vision problems and even blindness if not treated. This study will assess surabgene lomparvovec (sura-vec) as a potential one-time gene therapy administered in the suprachoroidal space (SCS) for the treatment of diabetic retinopathy (DR) and prevention of vision-threatening events (VTEs) in participants with non-proliferative DR (NPDR) without center-involved diabetic macular edema (CI-DME).

This study will consist of 3 portions: a Phase 2b portion, a Phase 3 portion, and a bilateral treatment portion. Approximately 576 adult participants will be enrolled in the study across multiple sites in the United States and Puerto Rico.

In the Phase 2b and Phase 3 portions, participants will be randomized to different groups to receive sura-vec and prophylactic steroids or sham and artificial tears in their study eye. If assigned to sham, participants will be given an opportunity to cross over and receive treatment with sura-vec. In the bilateral treatment portion, participants will be enrolled to receive sura-vec and prophylactic steroids in both eyes. In all 3 portions, follow-up in the study will continue through 5 years following administration of sura-vec in each eye.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

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Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Emanuelli Research & Development Center /ID# 275378, Arecibo, Puerto Rico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Ocular (Study Eye for Phase 2b and Phase 3 Portions; Both Eyes for Bilateral Portion)

  • Moderately severe or severe nonproliferative diabetic retinopathy (NPDR) (early treatment diabetic retinopathy study-diabetic retinopathy severity scale [DRSS] level 47 or 53) for which panretinal photocoagulation (PRP) or anti- vascular endothelial growth factor (VEGF) can be safely deferred for at least 6 months after Screening Visit 1.
  • Best-corrected visual acuity (BCVA) in the study eye of >= 69 Early treatment diabetic retinopathy study letters (approximate Snellen equivalent 20/40 or better) at Screening Visit 1.

Systemic

  • Diabetic retinopathy (DR) secondary to diabetes mellitus Type 1 or 2 with a hemoglobin A1c (HbA1c)< 12% within 60 days prior to Screening Visit 1.

Exclusion criteria

Ocular (Study Eye for Phase 2b and Phase 3 Portions; Both Eyes for Bilateral Portion)

  • Presence of active center involved-diabetic macular edema (CI-DME) in the study eye as determined by spectral domain optical coherence tomography (SD-OCT) evaluated by the central reading center (CRC), using the following threshold:

Central retinal thickness (CRT) >= 320 μm as measured by Heidelberg Spectralis SD-OCT (conversion to equivalent measurement is required and performed by the CRC if imaging is done with another SD-OCT instrument).

  • Active ocular inflammation including scleral inflammation (including episcleritis) or ocular/ periocular infection present in either eye at Screening Visit 1 or Screening Visit 2
  • Neovascularization from a cause other than DR, per investigator
  • Evidence or documented history of panretinal photocoagulation (PRP) or retinal laser therapy
  • History of intravitreal therapy, including anti-VEGF and long- or short-acting steroid therapy, within the prior 6 months and documentation of more than 10 prior anti-VEGF or short acting steroid intravitreal injections within 36 months of Screening Visit 1
  • Pregnant and breastfeeding individuals are excluded from this clinical study.

Systemic

  • Initiation of intensive insulin treatment (pump or multiple daily injections) within the past 6 months or plans to do so within 52 weeks after Day 1
  • Initiation of any treatment containing a GLP-1 receptor agonist within the 3 months prior to Screening Visit 1 or plans to do so within 52 weeks after Day 1
  • Pregnant and breastfeeding individuals are excluded from this clinical study

Treatment and study plan

Surabgene Lomparvovec

Drug

Solution Injection

sham

Drug

needleless injection without fluid

Topical Steroid

Drug

Topical Drops

Artificial Tears

Drug

Topical Drops

Primary outcomes

  1. Phase 2B: Percentage of Participants Achieving >= 2-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye

    Time frame: At Week 52

    The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.

  2. Phase 3: Percentage of Participants Achieving >= 2-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye

    Time frame: At Week 52

    The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.

  3. Bilateral Portion: Bilateral portion: Number of participants experiencing ocular Adverse Events (AEs), Serious Adverse Events (SAEs), or any Adverse Events of Special Interest (AESIs)

    Time frame: Up to Approximately Week 104

    Safety of bilateral administration with sura-vec will be assessed with Ocular AEs, SAEs, and AESIs. An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

  4. Bilateral Portion: Participants Who Experience Intraocular Inflammation

    Time frame: Up to Approximately Week 104

    Percentage of participants who experience intraocular inflammation.

  5. Bilateral Portion: Participants Who Experience Scleral Inflammation Including Episcleritis

    Time frame: Up to Approximately Week 104

    Percentage of participants who experience scleral inflammation including episcleritis.

Secondary outcomes

  1. Phase 2B: Percentage of Participants Who Develop a Vision-Threatening Event (VTE) due to Diabetic Retinopathy (DR)

    Time frame: Up to Approximately Week 52

    Participants will be assessed for the development of VTEs

  2. Phase 2B: Percentage of Participants Who Develop a Vision-Threatening Event (VTE) due to Diabetic Retinopathy (DR)

    Time frame: Up to Approximately Week 104

    Participants will be assessed for the development of VTEs

  3. Phase 2B: Percentage of Participants Who Experience Progression to Proliferative Diabetic Retinopathy (PDR) or Anterior Segment Neovascularization (ASNV) in the Study Eye

    Time frame: Up to Approximately Week 52

    Participants will be assessed for the progression to PDR or ASNV.

  4. Phase 2B: Percentage of Participants Who Experience Progression to Proliferative Diabetic Retinopathy (PDR) or Anterior Segment Neovascularization (ASNV) in the Study Eye

    Time frame: Up to Approximately Week 104

    Participants will be assessed for the progression to PDR or ASNV.

  5. Phase 2B: Percentage of Participants Who Develop Center Involved-Diabetic Macular Edema (CI-DME) in the Study Eye

    Time frame: Up to Approximately Week 52

    Participants will be assessed for the development of CI-DME.

  6. Phase 2B: Percentage of Participants Who Develop Center Involved-Diabetic Macular Edema (CI-DME) in the Study Eye

    Time frame: Up to Approximately Week 104

    Participants will be assessed for the development of CI-DME.

  7. Phase 2B: Percentage of Participants Achieving >= 2-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye

    Time frame: At Week 104

    The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.

  8. Phase 2B: Participants Who Develop Treatment-Emergent Ocular Inflammation in the Study Eye.

    Time frame: Up to approximately Week 14

    Percentage of participants who develop treatment-emergent ocular inflammation.

  9. Phase 2B: Participants Who Develop Treatment-Emergent Ocular Inflammation in the Study Eye.

    Time frame: Up to approximately Week 24

    Percentage of participants who develop treatment-emergent ocular inflammation.

  10. Phase 2B: Participants Who Develop Treatment-Emergent Ocular Inflammation in the Study Eye.

    Time frame: Up to approximately Week 38

    Percentage of participants who develop treatment-emergent ocular inflammation.

  11. Phase 2B: Participants Who Develop Treatment-Emergent Ocular Inflammation in the Study Eye.

    Time frame: Up to approximately Week 52

    Percentage of participants who develop treatment-emergent ocular inflammation.

  12. Phase 2B: Percentage of Participants Achieving>= 2-Step Worsening from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye

    Time frame: At Week 52

    The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.

  13. Phase 2B: Percentage of Participants Achieving >= 2-Step Worsening from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye

    Time frame: At Week 104

    The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.

  14. Phase 2B: Percentage of Participants With No Change from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye

    Time frame: At Week 52

    The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.

  15. Phase 2B: Percentage of participants With No Change from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye

    Time frame: At Week 104

    The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.

  16. Phase 2B: Percentage of Participants Achieving >= 2-Step or >= 3-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye.

    Time frame: At Week 52

    The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.

  17. Phase 2B: Percentage of Participants Achieving >= 2-Step or >= 3-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye.

    Time frame: At Week 104

    The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.

  18. Phase 2B: Percentage of Participants Achieving >= 3-Step Worsening from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye

    Time frame: At Week 52

    The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.

  19. Phase 2B: Percentage of Participants Achieving >= 3-Step Worsening from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye

    Time frame: At Week 104

    The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.

  20. Phase 2B: Participants With Change from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye

    Time frame: At Week 52

    The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.

  21. Phase 2B: Percentage of Participants With Change from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye

    Time frame: At Week 104

    The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.

  22. Phase 2B: Participants Who Develop Treatment-Emergent Ocular Inflammation in the Study Eye, Comparing 2 Topical Corticosteroid Regimens for Ocular Inflammation Prophylaxis

    Time frame: Up to approximately Week 14

    Percentage of participants who develop treatment-emergent ocular inflammation, comparing 2 topical corticosteroid regimens for ocular inflammation prophylaxis.

  23. Phase 2B: Participants Who Develop Treatment-Emergent Ocular Inflammation in the Study Eye, Comparing 2 Topical Corticosteroid Regimens for Ocular Inflammation Prophylaxis

    Time frame: Up to approximately Week 24

    Percentage of participants who develop treatment-emergent ocular inflammation, comparing 2 topical corticosteroid regimens for ocular inflammation prophylaxis.

  24. Phase 2B: Participants Who Develop Treatment-Emergent Ocular Inflammation in the Study Eye, Comparing 2 Topical Corticosteroid Regimens for Ocular Inflammation Prophylaxis

    Time frame: Up to approximately Week 38

    Percentage of participants who develop treatment-emergent ocular inflammation, comparing 2 topical corticosteroid regimens for ocular inflammation prophylaxis.

  25. Phase 2B: Participants Who Develop Treatment-Emergent Ocular Inflammation in the Study Eye, Comparing 2 Topical Corticosteroid Regimens for Ocular Inflammation Prophylaxis

    Time frame: Up to approximately Week 52

    Percentage of participants who develop treatment-emergent ocular inflammation, comparing 2 topical corticosteroid regimens for ocular inflammation prophylaxis.

  26. Phase 2B: Participants Who Receive Treatments for Diabetic Retinopathy (DR) Complications in the Study Eye

    Time frame: Up to Approximately Week 52

    Percentage of participants who receive treatments for DR complications in the study eye.

  27. Phase 2B: Participants Who Receive Treatments for Diabetic Retinopathy (DR) Complications in the Study Eye

    Time frame: Up to Approximately Week 104

    Percentage of participants who receive treatments for DR complications in the study eye.

  28. Phase 3 (key secondary): Percentage of Participants who develop a Vision-Threatening Event (VTE) due to Diabetic Retinopathy (DR)

    Time frame: Up to Approximately Week 52

    Participants will be assessed for the development of VTEs

  29. Phase 3 (key secondary): Percentage of Participants who develop a Vision-Threatening Event (VTE) due to Diabetic Retinopathy (DR)

    Time frame: Up to Approximately Week 104

    Participants will be assessed for the development of VTEs

  30. Phase 3 (key secondary): Percentage of Participants Who Experience Progression to Proliferative Diabetic Retinopathy (PDR) or Anterior Segment Neovascularization (ASNV) in the Study Eye

    Time frame: Up to Approximately Week 52

    Participants will be assessed for the progression to PDR or ASNV.

  31. Phase 3 (key secondary): Percentage of Participants Who Experience Progression to Proliferative Diabetic Retinopathy (PDR) or Anterior Segment Neovascularization (ASNV) in the Study Eye

    Time frame: Up to Approximately Week104

    Participants will be assessed for the progression to PDR or ASNV.

  32. Phase 3 (key secondary): Percentage of Participants Who Develop Center Involved-Diabetic Macular Edema (CI-DME) in the Study Eye

    Time frame: Up to Approximately Week 52

    Participants will be assessed for the development of CI-DME.

  33. Phase 3 (key secondary): Percentage of Participants Who Develop Center Involved-Diabetic Macular Edema (CI-DME) in the Study Eye

    Time frame: Up to Approximately Week 104

    Participants will be assessed for the development of CI-DME.

  34. Phase 3 (key secondary):Percentage of Participants Achieving >= 2-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye

    Time frame: At Week 104

    The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.

  35. Phase 3: Percentage of Participants Achieving >= 2-Step Worsening from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye

    Time frame: At Week 104

    The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.

  36. Phase 3: Percentage of Participants With No change from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye

    Time frame: At Week 52

    The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.

  37. Phase 3: Percentage of Participants With Change from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye

    Time frame: At Week 104

    The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.

  38. Phase 3: Percentage of Participants Achieving >= 2-Step or >= 3-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye.

    Time frame: At Week 52

    The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.

  39. Phase 3: Percentage of Participants Achieving >= 2-Step or >= 3-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye.

    Time frame: At Week 104

    The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.

  40. Phase 3: Percentage of Participants Achieving >= 3-Step Worsening from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye

    Time frame: At Week 52

    The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.

  41. Phase 3: Percentage of Participants Achieving >= 3-Step Worsening from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye

    Time frame: At Week 104

    The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.

  42. Phase 3: Percentage of Participants Who Receive Treatments for Diabetic Retinopathy (DR) Complications in the Study Eye

    Time frame: Up to approximately Week 52

    Percentage of participants who receive treatments for DR complications in the study eye.

  43. Phase 3: Percentage of Participants Who Receive Treatments for Diabetic Retinopathy (DR) Complications in the Study Eye

    Time frame: Up to approximately Week 104

    Percentage of participants who receive treatments for DR complications in the study eye.

  44. Bilateral Portion: Percentage of Participants Experiencing Nonocular Adverse Events (AE)s

    Time frame: Up to Approximately Week 104

    An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

  45. Bilateral Portion: Percentage of Participants Experiencing Nonocular Serious Adverse Events (SAE)s

    Time frame: Up to Approximately Week 104

    An SAE is defined as any AE, whether or not associated with study treatment that meets any of the following criteria: death of a participant, hospitalization or prolonged hospitalization, congenital anomaly, persistent or significant disability/incapacity, and important medical event requiring medical or surgical intervention to prevent serious outcome.

  46. Bilateral Portion: Percentage of Participants With Vector Shedding in Urine

    Time frame: Up to Approximately Week 12

    Vector shedding in urine is defined as measurement of vector Deoxyribonucleic Acid (DNA) concentrations in urine.

  47. Bilateral Portion: Percentage of Participants With Vector Shedding in Tears

    Time frame: Up to Approximately Week 12

    Vector shedding in tears is defined as measurement of vector DNA concentrations in tears.

  48. Bilateral Portion: Percentage of Participants With Vector DNA Concentrations in Serum

    Time frame: Up to Approximately Week 104

    Vector shedding in urine is defined as measurement of vector DNA concentrations in serum.

  49. Bilateral Portion: Percentage of Participants With Change from Baseline in Diabetic Retinopathy Severity Scale (DRSS) Level

    Time frame: Up to Approximately Week 104

    Change from baseline in DRSS level is defined as 0-step (no change), a ≥ 1-step, a ≥ 2-step, or a ≥ 3-step change.

  50. Bilateral Portion: Maintenance of Visual Acuity From Baseline

    Time frame: Up to Approximately Week 104

    Maintenance of visual acuity is defined as not losing 15 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters from baseline.

  51. Bilateral portion: Change from baseline in serum anti-sura-vec Transgene product (TP) antibodies

    Time frame: Up to Approximately Week 104

    Change from baseline in serum anti-sura-vec antibodies

  52. Bilateral Portion: Change from Baseline in Central Retinal Thickness (CRT) on Spectral Domain-Optical Coherence Tomography (SD-OCT)

    Time frame: Up to Approximately Week 104

    Change from baseline in CRT on SD-OCT.

  53. Bilateral Portion: Change from Baseline in Aqueous Humor Surabgene Lomparvovec (Sura-vec) Transgene product (TP) Concentration

    Time frame: Up to Approximately Week 104

    Change from baseline in aqueous humor sura-vec TP concentration.

  54. Bilateral Portion: Change from Baseline in Serum Sura-vec Transgene product (TP) concentration

    Time frame: Up to Approximately Week 104

    Change from baseline in serum sura-vec TP concentration.

  55. Bilateral Portion: Change from Baseline in Anti- Associated Virus Serotype 8 (AAV8) Transgene product (TP) antibodies

    Time frame: Up to Approximately Week 104

    Change from baseline in serum anti-AAV8 TP antibodies.

  56. Bilateral Portion: Percentage of Participants who develop a Vision-Threatening Event (VTE) due to Diabetic Retinopathy (DR)

    Time frame: Up to Approximately Week 104

    Participants will be assessed for the development of VTEs

  57. Bilateral Portion: Change from Baseline in Enzyme-linked ImmunoSpot (ELISpot to capsid or transgene)

    Time frame: Up to Approximately Week 104

    Change from baseline in ELISpot comparing (whole blood) to capsid or transgene.

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

An Operationally Seamless Phase 2b/3, Multicenter, Randomized, Masked, Sham-controlled Study to Evaluate the Efficacy and Safety of Surabgene Lomparvovec (Sura-vec) Delivered Via Suprachoroidal Space (SCS) Injection Targeting Subjects With Diabetic Retinopathy Without Center Involved-Diabetic Macular Edema (CI-DME) (NAAVIGATE)

Acronym: NAAVIGATE

Important dates

Study start
2026
Primary completion
2028
Study completion
2036
First posted
May 18, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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