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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 2b: Surabgene Lomparvovec + Steroid-Regimen A | Experimental | Participants will receive a single Suprachoroidal space (SCS) injection dose of surabgene lomparvovec (sura-vec) + steroid-Regimen A. |
|
| Phase 2b: Surabgene Lomparvovec + Steroid-Regimen B | Experimental | Participants will receive a single SCS injection dose of surabgene lomparvovec (sura-vec) + steroid-Regimen B. |
|
| Phase 2b: Sham + Artificial Tears -Regimen A | Placebo Comparator | Participants will receive a single injection of sham+ artificial tears -Regimen A. |
|
| Phase 2b: Sham + Artificial Tears -Regimen B | Placebo Comparator | Participants will receive a single injection of Sham+ artificial tears -Regimen B. |
|
| Phase 3: Surabgene Lomparvovec + Steroid | Experimental | Participants will receive a single SCS injection dose of Surabgene Lomparvovec + Steroid |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surabgene Lomparvovec | Drug | Solution Injection |
|
| 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 |
| 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) |
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Inclusion Criteria:
Ocular (Study Eye for Phase 2b and Phase 3 Portions; Both Eyes for Bilateral Portion)
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)
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).
Systemic
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | Contact | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northern California Retina Vitreous Associates /ID# 282994 | Recruiting | Mountain View | California | 94040-4119 | United States |
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.
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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|
| Phase 3: Sham + Artificial Tears | Placebo Comparator | Participants will receive a single injection of Sham + artificial tears. |
|
| Bilateral: B1-Surabgene Lomparvovec + Steroid | Experimental | Participants will receive a single SCS injection dose of Surabgene Lomparvovec + Steroid eye drops in each eye. |
|
| Bilateral: B2-Surabgene Lomparvovec + Steroid | Experimental | Participants will receive a single SCS injection dose of Surabgene Lomparvovec +Steroid eye drops in each eye. |
|
| Sham | Drug | needleless injection without fluid |
|
| Topical Steroid | Drug | Topical Drops |
|
| Artificial Tears | Drug | Topical Drops |
|
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 |
| Macula Retina Vitreous Center - Torrance /ID# 282878 | Recruiting | Torrance | California | 90503 | United States |
| Southwest Retina Research Center /ID# 276094 | Recruiting | Durango | Colorado | 81303 | United States |
| Florida Retina Consultants - Lakeland /ID# 275012 | Recruiting | Lakeland | Florida | 33805 | United States |
| University Retina - Oak Forest /ID# 283021 | Recruiting | Oak Forest | Illinois | 60452 | United States |
| Mid Atlantic Retina Specialists - Hagerstown /ID# 274725 | Recruiting | Hagerstown | Maryland | 21740 | United States |
| Sierra Eye Associates /ID# 274737 | Recruiting | Reno | Nevada | 89502 | United States |
| Retina Associates Of Cleveland - Beachwood /ID# 275985 | Recruiting | Beachwood | Ohio | 44122 | United States |
| Austin Research Center for Retina /ID# 276101 | Recruiting | Austin | Texas | 78705 | United States |
| Star Retina /ID# 276513 | Recruiting | Burleson | Texas | 76028 | United States |
| Texas Retina Associates - Dallas /ID# 276117 | Recruiting | Dallas | Texas | 75231 | United States |
| Vistar Eye Center - Salem /ID# 282879 | Recruiting | Salem | Virginia | 24153 | United States |
| Emanuelli Research & Development Center /ID# 275378 | Recruiting | Arecibo | 00612 | Puerto Rico |
| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
| D013256 | Steroids |
| D065346 | Lubricant Eye Drops |
| ID | Term |
|---|---|
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D009883 | Ophthalmic Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D054327 | Lubricants |
| D020313 | Specialty Uses of Chemicals |
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