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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Retinopathy
• Intervention / Treatment: Drug: Surabgene Lomparvovec; Drug: Topical Steroid; Drug: Sham; Drug: Artificial Tears

• Study Type: Interventional
• Enrollment (Estimated): 576
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• United States
  • Illinois
    • Oak Forest, Illinois, United States, 60452
      • Recruiting
      • University Retina - Oak Forest /ID# 283021
  • Texas
    • Austin, Texas, United States, 78705
      • Recruiting
      • Austin Research Center for Retina /ID# 276101

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 2b: Surabgene Lomparvovec + Steroid-Regimen A; Participants will receive a single Suprachoroidal space (SCS) injection dose of surabgene lomparvovec (sura-vec) + steroid-Regimen A.	Drug: Surabgene Lomparvovec; Solution Injection; Drug: Topical Steroid; Topical Drops
Experimental: Phase 2b: Surabgene Lomparvovec + Steroid-Regimen B; Participants will receive a single SCS injection dose of surabgene lomparvovec (sura-vec) + steroid-Regimen B.	Drug: Surabgene Lomparvovec; Solution Injection; Drug: Topical Steroid; Topical Drops
Placebo Comparator: Phase 2b: Sham + Artificial Tears -Regimen A; Participants will receive a single injection of sham+ artificial tears -Regimen A.	Drug: Sham; needleless injection without fluid; Drug: Artificial Tears; Topical Drops
Placebo Comparator: Phase 2b: Sham + Artificial Tears -Regimen B; Participants will receive a single injection of Sham+ artificial tears -Regimen B.	Drug: Sham; needleless injection without fluid; Drug: Artificial Tears; Topical Drops
Experimental: Phase 3: Surabgene Lomparvovec + Steroid; Participants will receive a single SCS injection dose of Surabgene Lomparvovec + Steroid	Drug: Surabgene Lomparvovec; Solution Injection; Drug: Topical Steroid; Topical Drops
Placebo Comparator: Phase 3: Sham + Artificial Tears; Participants will receive a single injection of Sham + artificial tears.	Drug: Sham; needleless injection without fluid; Drug: Artificial Tears; Topical Drops
Experimental: Bilateral: B1-Surabgene Lomparvovec + Steroid; Participants will receive a single SCS injection dose of Surabgene Lomparvovec + Steroid eye drops in each eye.	Drug: Surabgene Lomparvovec; Solution Injection; Drug: Topical Steroid; Topical Drops
Experimental: Bilateral: B2-Surabgene Lomparvovec + Steroid; Participants will receive a single SCS injection dose of Surabgene Lomparvovec +Steroid eye drops in each eye.	Drug: Surabgene Lomparvovec; Solution Injection; Drug: Topical Steroid; Topical Drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 2B: Percentage of Participants Achieving >= 2-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye	The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.	At Week 52
Phase 3: Percentage of Participants Achieving >= 2-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye	The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.	At Week 52
Bilateral Portion: Bilateral portion: Number of participants experiencing ocular Adverse Events (AEs), Serious Adverse Events (SAEs), or any Adverse Events of Special Interest (AESIs)	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.	Up to Approximately Week 104
Bilateral Portion: Participants Who Experience Intraocular Inflammation	Percentage of participants who experience intraocular inflammation.	Up to Approximately Week 104
Bilateral Portion: Participants Who Experience Scleral Inflammation Including Episcleritis	Percentage of participants who experience scleral inflammation including episcleritis.	Up to Approximately Week 104

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 2B: Percentage of Participants Who Develop a Vision-Threatening Event (VTE) due to Diabetic Retinopathy (DR)	Participants will be assessed for the development of VTEs	Up to Approximately Week 52
Phase 2B: Percentage of Participants Who Develop a Vision-Threatening Event (VTE) due to Diabetic Retinopathy (DR)	Participants will be assessed for the development of VTEs	Up to Approximately Week 104
Phase 2B: Percentage of Participants Who Experience Progression to Proliferative Diabetic Retinopathy (PDR) or Anterior Segment Neovascularization (ASNV) in the Study Eye	Participants will be assessed for the progression to PDR or ASNV.	Up to Approximately Week 52
Phase 2B: Percentage of Participants Who Experience Progression to Proliferative Diabetic Retinopathy (PDR) or Anterior Segment Neovascularization (ASNV) in the Study Eye	Participants will be assessed for the progression to PDR or ASNV.	Up to Approximately Week 104
Phase 2B: Percentage of Participants Who Develop Center Involved-Diabetic Macular Edema (CI-DME) in the Study Eye	Participants will be assessed for the development of CI-DME.	Up to Approximately Week 52
Phase 2B: Percentage of Participants Who Develop Center Involved-Diabetic Macular Edema (CI-DME) in the Study Eye	Participants will be assessed for the development of CI-DME.	Up to Approximately Week 104
Phase 2B: Percentage of Participants Achieving >= 2-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye	The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.	At Week 104
Phase 2B: Participants Who Develop Treatment-Emergent Ocular Inflammation in the Study Eye.	Percentage of participants who develop treatment-emergent ocular inflammation.	Up to approximately Week 14
Phase 2B: Participants Who Develop Treatment-Emergent Ocular Inflammation in the Study Eye.	Percentage of participants who develop treatment-emergent ocular inflammation.	Up to approximately Week 24
Phase 2B: Participants Who Develop Treatment-Emergent Ocular Inflammation in the Study Eye.	Percentage of participants who develop treatment-emergent ocular inflammation.	Up to approximately Week 38
Phase 2B: Participants Who Develop Treatment-Emergent Ocular Inflammation in the Study Eye.	Percentage of participants who develop treatment-emergent ocular inflammation.	Up to approximately Week 52
Phase 2B: Percentage of Participants Achieving>= 2-Step Worsening from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye	The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.	At Week 52
Phase 2B: Percentage of Participants Achieving >= 2-Step Worsening from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye	The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.	At Week 104
Phase 2B: Percentage of Participants With No Change from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye	The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.	At Week 52
Phase 2B: Percentage of participants With No Change from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye	The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.	At Week 104
Phase 2B: Percentage of Participants Achieving >= 2-Step or >= 3-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye.	The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.	At Week 52
Phase 2B: Percentage of Participants Achieving >= 2-Step or >= 3-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye.	The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.	At Week 104
Phase 2B: Percentage of Participants Achieving >= 3-Step Worsening from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye	The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.	At Week 52
Phase 2B: Percentage of Participants Achieving >= 3-Step Worsening from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye	The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.	At Week 104
Phase 2B: Participants With Change from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye	The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.	At Week 52
Phase 2B: Percentage of Participants With Change from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye	The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.	At Week 104
Phase 2B: Participants Who Develop Treatment-Emergent Ocular Inflammation in the Study Eye, Comparing 2 Topical Corticosteroid Regimens for Ocular Inflammation Prophylaxis	Percentage of participants who develop treatment-emergent ocular inflammation, comparing 2 topical corticosteroid regimens for ocular inflammation prophylaxis.	Up to approximately Week 14
Phase 2B: Participants Who Develop Treatment-Emergent Ocular Inflammation in the Study Eye, Comparing 2 Topical Corticosteroid Regimens for Ocular Inflammation Prophylaxis	Percentage of participants who develop treatment-emergent ocular inflammation, comparing 2 topical corticosteroid regimens for ocular inflammation prophylaxis.	Up to approximately Week 24
Phase 2B: Participants Who Develop Treatment-Emergent Ocular Inflammation in the Study Eye, Comparing 2 Topical Corticosteroid Regimens for Ocular Inflammation Prophylaxis	Percentage of participants who develop treatment-emergent ocular inflammation, comparing 2 topical corticosteroid regimens for ocular inflammation prophylaxis.	Up to approximately Week 38
Phase 2B: Participants Who Develop Treatment-Emergent Ocular Inflammation in the Study Eye, Comparing 2 Topical Corticosteroid Regimens for Ocular Inflammation Prophylaxis	Percentage of participants who develop treatment-emergent ocular inflammation, comparing 2 topical corticosteroid regimens for ocular inflammation prophylaxis.	Up to approximately Week 52
Phase 2B: Participants Who Receive Treatments for Diabetic Retinopathy (DR) Complications in the Study Eye	Percentage of participants who receive treatments for DR complications in the study eye.	Up to Approximately Week 52
Phase 2B: Participants Who Receive Treatments for Diabetic Retinopathy (DR) Complications in the Study Eye	Percentage of participants who receive treatments for DR complications in the study eye.	Up to Approximately Week 104
Phase 3 (key secondary): Percentage of Participants who develop a Vision-Threatening Event (VTE) due to Diabetic Retinopathy (DR)	Participants will be assessed for the development of VTEs	Up to Approximately Week 52
Phase 3 (key secondary): Percentage of Participants who develop a Vision-Threatening Event (VTE) due to Diabetic Retinopathy (DR)	Participants will be assessed for the development of VTEs	Up to Approximately Week 104
Phase 3 (key secondary): Percentage of Participants Who Experience Progression to Proliferative Diabetic Retinopathy (PDR) or Anterior Segment Neovascularization (ASNV) in the Study Eye	Participants will be assessed for the progression to PDR or ASNV.	Up to Approximately Week 52
Phase 3 (key secondary): Percentage of Participants Who Experience Progression to Proliferative Diabetic Retinopathy (PDR) or Anterior Segment Neovascularization (ASNV) in the Study Eye	Participants will be assessed for the progression to PDR or ASNV.	Up to Approximately Week104
Phase 3 (key secondary): Percentage of Participants Who Develop Center Involved-Diabetic Macular Edema (CI-DME) in the Study Eye	Participants will be assessed for the development of CI-DME.	Up to Approximately Week 52
Phase 3 (key secondary): Percentage of Participants Who Develop Center Involved-Diabetic Macular Edema (CI-DME) in the Study Eye	Participants will be assessed for the development of CI-DME.	Up to Approximately Week 104
Phase 3 (key secondary):Percentage of Participants Achieving >= 2-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye	The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.	At Week 104
Phase 3: Percentage of Participants Achieving >= 2-Step Worsening from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye	The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.	At Week 104
Phase 3: Percentage of Participants With No change from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye	The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.	At Week 52
Phase 3: Percentage of Participants With Change from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye	The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.	At Week 104
Phase 3: Percentage of Participants Achieving >= 2-Step or >= 3-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye.	The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.	At Week 52
Phase 3: Percentage of Participants Achieving >= 2-Step or >= 3-Step Improvement from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye.	The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.	At Week 104
Phase 3: Percentage of Participants Achieving >= 3-Step Worsening from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye	The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.	At Week 52
Phase 3: Percentage of Participants Achieving >= 3-Step Worsening from Baseline in Diabetic Retinopathy Severity Scale (DRSS) in the Study Eye	The DRSS is a scale the measures the severity of DR with a higher score indicating greater severity.	At Week 104
Phase 3: Percentage of Participants Who Receive Treatments for Diabetic Retinopathy (DR) Complications in the Study Eye	Percentage of participants who receive treatments for DR complications in the study eye.	Up to approximately Week 52
Phase 3: Percentage of Participants Who Receive Treatments for Diabetic Retinopathy (DR) Complications in the Study Eye	Percentage of participants who receive treatments for DR complications in the study eye.	Up to approximately Week 104
Bilateral Portion: Percentage of Participants Experiencing Nonocular Adverse Events (AE)s	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.	Up to Approximately Week 104
Bilateral Portion: Percentage of Participants Experiencing Nonocular Serious Adverse Events (SAE)s	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.	Up to Approximately Week 104
Bilateral Portion: Percentage of Participants With Vector Shedding in Urine	Vector shedding in urine is defined as measurement of vector Deoxyribonucleic Acid (DNA) concentrations in urine.	Up to Approximately Week 12
Bilateral Portion: Percentage of Participants With Vector Shedding in Tears	Vector shedding in tears is defined as measurement of vector DNA concentrations in tears.	Up to Approximately Week 12
Bilateral Portion: Percentage of Participants With Vector DNA Concentrations in Serum	Vector shedding in urine is defined as measurement of vector DNA concentrations in serum.	Up to Approximately Week 104
Bilateral Portion: Percentage of Participants With Change from Baseline in Diabetic Retinopathy Severity Scale (DRSS) Level	Change from baseline in DRSS level is defined as 0-step (no change), a ≥ 1-step, a ≥ 2-step, or a ≥ 3-step change.	Up to Approximately Week 104
Bilateral Portion: Maintenance of Visual Acuity From Baseline	Maintenance of visual acuity is defined as not losing 15 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters from baseline.	Up to Approximately Week 104
Bilateral portion: Change from baseline in serum anti-sura-vec Transgene product (TP) antibodies	Change from baseline in serum anti-sura-vec antibodies	Up to Approximately Week 104
Bilateral Portion: Change from Baseline in Central Retinal Thickness (CRT) on Spectral Domain-Optical Coherence Tomography (SD-OCT)	Change from baseline in CRT on SD-OCT.	Up to Approximately Week 104
Bilateral Portion: Change from Baseline in Aqueous Humor Surabgene Lomparvovec (Sura-vec) Transgene product (TP) Concentration	Change from baseline in aqueous humor sura-vec TP concentration.	Up to Approximately Week 104
Bilateral Portion: Change from Baseline in Serum Sura-vec Transgene product (TP) concentration	Change from baseline in serum sura-vec TP concentration.	Up to Approximately Week 104
Bilateral Portion: Change from Baseline in Anti- Associated Virus Serotype 8 (AAV8) Transgene product (TP) antibodies	Change from baseline in serum anti-AAV8 TP antibodies.	Up to Approximately Week 104
Bilateral Portion: Percentage of Participants who develop a Vision-Threatening Event (VTE) due to Diabetic Retinopathy (DR)	Participants will be assessed for the development of VTEs	Up to Approximately Week 104
Bilateral Portion: Change from Baseline in Enzyme-linked ImmunoSpot (ELISpot to capsid or transgene)	Change from baseline in ELISpot comparing (whole blood) to capsid or transgene.	Up to Approximately Week 104

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): May 20, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): January 1, 2036

Study Registration Dates

• First Submitted: April 24, 2026
• First Submitted That Met QC Criteria: May 11, 2026
• First Posted (Actual): May 18, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Diabetic Retinopathy; ABBV-RGX-314; Severe Nonproliferative Diabetic Retinopathy
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Eye Diseases; Diabetic Angiopathies; Diabetes Complications; Retinal Diseases; Diabetic Retinopathy; Ophthalmic Solutions; Pharmaceutical Solutions; Pharmaceutical Preparations; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Polycyclic Compounds; Fused-Ring Compounds; Solutions; Specialty Uses of Chemicals; Lubricants; Lubricant Eye Drops; salicylhydroxamic acid; Steroids
• Other Study ID Numbers: M23-415

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
• IPD Sharing Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No