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A Phase 2, Multi-Center, Randomized, Double-Masked*, Active Controlled Study of ADVM-022 (AAV.7m8-aflibercept) in Subjects with Diabetic Macular Edema [INFINITY]
ADVM-022 (also known as Ixo-vec and AAV.7m8-aflibercept) is an investigational gene therapy product developed for the treatment of serious retinal vascular diseases including Diabetic Macular Edema (DME), a vision-threatening complication of diabetic retinopathy. DME can affect up to 10% of individuals with both type 1 and type 2 diabetes mellitus. Current therapies for treating DME include anti-vascular endothelial growth factor (anti-VEGF) agents that require frequent and long-term intravitreal (IVT) injections to achieve and maintain efficacy. ADVM-022 is intended provide sustained intraocular expression of aflibercept from a single IVT injection to potentially reduce the current treatment burden and prevent disease progression and vision loss due to undertreatment.
This Phase 2, randomized, controlled study (INFINITY) enrolled 36 eligible participants with DME. The participants were randomized to receive one of the two dose levels of ADVM-022 or assigned to the control arm to receive a sham ocular injection with a preceding aflibercept injection. Participants randomized to the ADVM-022 arms were assigned to receive a preceding aflibercept or sham ocular injection. All participants were monitored regularly for disease activity and may have received supplemental aflibercept based on predefined retreatment criteria. All participants were to be followed over a 96- week follow-up period.
To enhance safety monitoring for participants in this study, the sponsor unmasked treatment assignment (in April 2021) due to the occurrence of a suspected unexpected serious adverse reaction (SUSAR) which occurred early in the study in the high dose (ADVM-022 6E11 vg/eye) arm. Interpretation of the results of this study should consider the potential confounding nature of this unmasking in the context of the observed dose-limiting events and the associated additional use of topical/intravitreal/systemic steroids, particularly in the high dose ADVM-022 arm.
In this study ADVM-022 (Ixo-vec) demonstrated improved efficacy across endpoints, reducing the need for supplemental aflibercept in DME management and demonstrating a clinically meaningful delay in DME worsening and improved outcomes across multiple endpoints compared to the control arm (sham + Aflibercept). However, the benefit of the ADVM-022 6E11 vg/eye dose was affected by dose-limiting toxicities in some participants. In terms of safety outcomes, the most common ADVM-022-related adverse events were mild-to-moderate intraocular inflammation, a known and expected side effect of ocular gene therapy, which was generally responsive to corticosteroid eye drops. No Ixo-vec-related events were reported in the fellow eye or systemically, indicating no off-target effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT |
|
| 2 | Experimental | 2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT |
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| 3 | Active Comparator | Aflibercept 2mg IVT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 6E11 vg/eye of ADVM-022 | Biological | ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Worsening of DME Disease Activity in the Study Eye. | Time to worsening of DME disease activity in the study eye through 96 weeks. Time to worsening of DME disease activity defined by either: An increase in CST > 50 µm as assessed by SD-OCT compared to the lower of the two CST measurements recorded at Day 1 or Week 4; A loss of > 5 letters in BCVA due to worsening DME disease activity compared to the higher of the two BCVA measurements recorded at Day 1 or Week 4. Number of weeks was relative to Day 1. | Day 1 through 96 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Ocular Adverse Events (AEs) | Incidence of ocular adverse events (AEs) through 96 weeks | 96 weeks |
| Incidence of Non-ocular Adverse Events (AEs) | Incidence of non-ocular adverse events (AEs) through 96 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| INFINITY Medical Monitor, MD | Adverum Biotechnologies, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adverum Clinical Site | Phoenix | Arizona | 85014 | United States | ||
| Adverum Clinical Site |
Participants with initial diagnosis of DME within 6 months of screening, and who had received up to 2 prior injections of anti-VEGF therapy in the study eye (0, 1 or 2) were eligible for enrollment. If a prior anti-VEGF had been administered to the study eye, in the judgement of the Investigator, there must have been a meaningful CST response (e.g., ≥ 10% reduction) and no adverse reaction to the anti-VEGF (e.g., intraocular inflammation).
Two doses of ADVM-022 (Ixo-vec) were investigated, administered with or without a prior loading dose of Aflibercept. The control group received the initial loading dose of Aflibercept (Day 1) but received a Sham injection on Day 8 instead of Ixo-vec. Only one eye was selected as the study eye. After the assigned intravitreal (IVT) injections on Days 1 and 8, clinic visits were on Weeks 2, 4, and every 4 weeks up to Week 96. Consenting participants then entered a long-term follow-up study.
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| ID | Title | Description |
|---|---|---|
| FG000 | ADVM-022 6E11 vg/Eye | 6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 6E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 5, 2021 | Jun 17, 2025 |
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From May 2020 through April 2021: Double-masked study - participants, outcomes assessors and the designated masked study personnel were to have been masked to subject's treatment assignment throughout the study. There must have been a minimum of two physicians per site to fulfill the masking requirements of the study. A masked and unmasked investigator were required to be present for administration of the preceding dose of aflibercept or sham and following dose of ADVM-022 or sham visits, thereafter only the masked investigator was required to be present.
Starting April 2021: Open label study - study was unmasked for enhanced safety monitoring.
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|
| 2E11 vg/eye of ADVM-022 | Biological | ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept |
|
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| Aflibercept | Biological | Commercially available Active Comparator |
|
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| Day 1 through 96 weeks |
| Change From Baseline Central Subfield Thickness (CST) in Study Eye | Central subfield thickness is a measurement of the thickness of the retina in a circular area around the fovea. Least squares mean change from Baseline in central subfield thickness at Week 96 is presented for the study eye. | Baseline through 96 weeks |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) Score Over Time in the Study Eye | Least squares mean change from Baseline in BCVA score over time was measured over time through week 96 in the study eye by ETDRS letters. | 96 weeks |
| Frequency of Supplemental Aflibercept Injections (2 mg IVT) in the Study Eye Over Time During the Study | Frequency of supplemental aflibercept (2 mg IVT) injections was assessed in the study eye over time during the study. Participants were analyzed according to the study treatments they actually received on Days 1 and 8. The rate of supplemental aflibercept per year = Total number of supplemental aflibercept injections / Total years at-risk (at-risk duration starting at Day 8). | Day 1 through 96 weeks |
| Incidence of 2-step Improvement in Diabetic Retinopathy Severity Score (DRSS) in the Study Eye Over Time | Diabetic Retinopathy Severity Score was determined by the Central Reading Center using ultra-wide field color retinopathy fundus photography. The score represents a comprehensive evaluation of retinal health, including the presence of microaneurysms, hemorrhages, and other abnormalities in the retina of the study eye. The score ranges from 10 to 85 and is divided into 13-steps used to classify increasing diabetic retinopathy severity (with higher scored indicating more advanced stages of Diabetic Retinopathy). In this endpoint a 2-step improvement indicates an improvement in a participant across 2 steps of the 13-step scale. | From Day 1 through 96 weeks |
| Incidence of 3-step Improvement in DRSS (Diabetic Retinopathy Severity Score) in the Study Eye Over Time | Diabetic Retinopathy Severity Score was determined by the Central Reading Center using ultra-wide field color retinopathy fundus photography. The score represents a comprehensive evaluation of retinal health, including the presence of microaneurysms, hemorrhages, and other abnormalities in the retina of the study eye. The score ranges from 10 to 85 and is divided into 13-steps used to classify increasing diabetic retinopathy severity (with higher scored indicating more advanced stages of Diabetic Retinopathy). In this endpoint a 3-step improvement indicates an improvement in a participant across 3 steps of the 13-step scale. | From Day 1 through 96 weeks |
| Incidence of 2-step Worsening in DRSS (Diabetic Retinopathy Severity Score) in the Study Eye Over Time | Diabetic Retinopathy Severity Score was determined by the Central Reading Center using ultra-wide field color retinopathy fundus photography. The score represents a comprehensive evaluation of retinal health, including the presence of microaneurysms, hemorrhages, and other abnormalities in the retina of the study eye. The score ranges from 10 to 85 and is divided into 13-steps used to classify increasing diabetic retinopathy severity (with higher scored indicating more advanced stages of Diabetic Retinopathy). In this endpoint a 2-step worsening indicates a worsening across 2 steps of the 13-step scale. Note: 2-step worsening in DRSS was observed in 2 participants in both the control arm and the ADVM-022 6E11 vg/eye arm. These participants experienced ocular adverse events which may have contributed, at least in part, to the worsening in DRSS. This included one participant in the ADVM-022 6E11 vg/eye arm who had a SUSAR of Hypotony of eye (secondary to intraocular inflammation). | From Day 1 through 96 weeks |
| Incidence of 3-step Worsening in DRSS (Diabetic Retinopathy Severity Score) in the Study Eye Over Time | Diabetic Retinopathy Severity Score was determined by the Central Reading Center using ultra-wide field color retinopathy fundus photography. The score represents a comprehensive evaluation of retinal health, including the presence of microaneurysms, hemorrhages, and other abnormalities in the retina of the study eye. The score ranges from 10 to 85 with higher scored indicating more advanced stages of Diabetic Retinopathy. The incidence of 3-step worsening in DRSS score over time at Week 96 is presented. Visits with a 3-step or greater worsening in DRSS were considered separate events. Note: 3-step worsening in DRSS was observed in one participant each in the control arm and the ADVM-022 6E11 vg/eye arm. Both participants experienced ocular adverse events which may have contributed, at least in part, to the worsening in DRSS. This included one participant in the ADVM-022 6E11 vg/eye arm who had a SUSAR of Hypotony of eye (secondary to intraocular inflammation). | From Day 1 through 96 weeks |
| Occurrence of Any Vision Threatening Complications in the Study Eye (Anterior Segment Neovascularization, Vitreous Hemorrhage, or Any Other High-risk Proliferative DR, or Tractional Retinal Detachment) Over Time Through Week 96 | Occurrence of any vision threatening complication over time though 96 weeks. Results present the incidence of participants who experienced "Any Vision Threatening Complications" (defined as any Vitreous Haemorrhage adverse event (AE), Anterior Segment Neovascularization AE, High-risk proliferative DR (defined as DSSR >= 71), or Tractional Retinal Detachment AE) in the study eye from Day 1 through 96 weeks. Note: AEs of Vitreous Haemorrhage and High-risk proliferative DR were reported in 1 participant in the control arm and in 2 separate participants in the 6E11 vg/eye arm. No AE of Tractional Retinal Detachment or Anterior Segment Neovascularization occurred. | From Day 1 through 96 weeks |
| Incidence of CST <300 μm Over Time Through Week 96 in the Study Eye | Central subfield thickness is a measurement of the thickness of the retina in a circular area around the fovea. Incidence of participants with Central subfield thickness of less than 300 μm over time in the study eye through Week 96 is presented. | Day 1 through 96 weeks |
| Bakersfield |
| California |
| 93309 |
| United States |
| Adverum Clinical Site | Beverly Hills | California | 90211 | United States |
| Adverum Clinical Site | Golden | Colorado | 80401 | United States |
| Adverum Clinical Site | Deerfield Beach | Florida | 33064 | United States |
| Adverum Clinical Site | Reno | Nevada | 89502 | United States |
| Adverum Clinical Site | Philadelphia | Pennsylvania | 19107 | United States |
| Adverum Clinical Site | West Columbia | South Carolina | 29169 | United States |
| Adverum Clinical Site | Nashville | Tennessee | 37203 | United States |
| Adverum Clinical Site | Abilene | Texas | 79606 | United States |
| Adverum Clinical Site | Austin | Texas | 78705 | United States |
| Adverum Clinical Site | Houston | Texas | 77030 | United States |
| Adverum Clinical Site | The Woodlands | Texas | 77384 | United States |
| Adverum Clinical Site | Arecibo | 00612 | Puerto Rico |
| ADVM-022 2E11 vg/Eye |
2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 2E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator |
| FG002 | Aflibercept + Sham | Aflibercept 2mg IVT Aflibercept: Commercially available Active Comparator |
| Modified ITT (mITT) Population | The modified ITT (mITT) population included all randomized participants who received study treatment at both Day 1 (Aflibercept or Sham) and Day 8 (ADVM-022 or Sham). Two participants (1 randomized to ADVM-022-6E11 vg/Eye and 1 randomized to Aflibercept + Sham) treated on Day 1 were withdrawn by the Sponsor prior to Day 8 due to the syringe manufacturer warning letter (in the UK) advising against intra-ocular use. These two participants are not included in mITT. They reported no adverse events. |
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| COMPLETED |
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| NOT COMPLETED |
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ITT (Intent to Treat) Population included all participants randomized to treatment. Participants were analyzed as randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | ADVM-022 6E11 vg/Eye | 6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 6E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator |
| BG001 | ADVM-022 2E11 vg/Eye | 2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 2E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator |
| BG002 | Aflibercept + Sham | Aflibercept 2mg IVT Aflibercept: Commercially available Active Comparator |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Worsening of DME Disease Activity in the Study Eye. | Time to worsening of DME disease activity in the study eye through 96 weeks. Time to worsening of DME disease activity defined by either: An increase in CST > 50 µm as assessed by SD-OCT compared to the lower of the two CST measurements recorded at Day 1 or Week 4; A loss of > 5 letters in BCVA due to worsening DME disease activity compared to the higher of the two BCVA measurements recorded at Day 1 or Week 4. Number of weeks was relative to Day 1. | The Modified Intent to Treat population (mITT) was analyzed for this endpoint (mITT population includes all randomized participants who received study treatment at both Day 1 [Aflibercept or Sham] and Day 8 [Ixo-vec or Sham]). | Posted | Median | 90% Confidence Interval | Weeks | Day 1 through 96 weeks | Study Eyes | Study Eyes |
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| Secondary | Incidence of Ocular Adverse Events (AEs) | Incidence of ocular adverse events (AEs) through 96 weeks | mITT population: participants who received treatment on Day 1 (aflibercept or Sham) and Day 8 (Ixo-vec or Sham) analyzed based on treatments they received on Days 1 and 8. Ocular adverse events are presented for the Study Eye only. Note: two participants who were discontinued prior to Day 8 are not included in the mITT population. These two participants reported no adverse events. | Posted | Count of Participants | Participants | 96 weeks |
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| Secondary | Incidence of Non-ocular Adverse Events (AEs) | Incidence of non-ocular adverse events (AEs) through 96 weeks. | mITT population: participants who received treatment on Day 1 (aflibercept or Sham) and Day 8 (Ixo-vec or Sham) analyzed based on treatments they received on Days 1 and 8. Note: two participants who were discontinued prior to Day 8 are not included in the mITT population. These two participants reported no adverse events. | Posted | Count of Participants | Participants | Day 1 through 96 weeks |
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| Secondary | Change From Baseline Central Subfield Thickness (CST) in Study Eye | Central subfield thickness is a measurement of the thickness of the retina in a circular area around the fovea. Least squares mean change from Baseline in central subfield thickness at Week 96 is presented for the study eye. | The Modified Intent to Treat population (mITT) was analyzed for this endpoint (mITT population includes all randomized participants who received study treatment at both Day 1 [Aflibercept or Sham] and Day 8 [Ixo-vec or Sham]). | Posted | Least Squares Mean | 90% Confidence Interval | micrometers | Baseline through 96 weeks | Study Eyes | Study Eyes |
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| Secondary | Change From Baseline in Best Corrected Visual Acuity (BCVA) Score Over Time in the Study Eye | Least squares mean change from Baseline in BCVA score over time was measured over time through week 96 in the study eye by ETDRS letters. | The Modified Intent to Treat population (mITT) was analyzed for this endpoint (mITT population includes all randomized participants who received study treatment at both Day 1 [Aflibercept or Sham] and Day 8 [Ixo-vec or Sham]). | Posted | Least Squares Mean | 90% Confidence Interval | ETDRS letters | 96 weeks | Study Eyes | Study Eyes |
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| Secondary | Frequency of Supplemental Aflibercept Injections (2 mg IVT) in the Study Eye Over Time During the Study | Frequency of supplemental aflibercept (2 mg IVT) injections was assessed in the study eye over time during the study. Participants were analyzed according to the study treatments they actually received on Days 1 and 8. The rate of supplemental aflibercept per year = Total number of supplemental aflibercept injections / Total years at-risk (at-risk duration starting at Day 8). | The Modified Intent to Treat population (mITT) was analyzed for this endpoint (mITT population includes all randomized participants who received study treatment at both Day 1 [Aflibercept or Sham] and Day 8 [Ixo-vec or Sham]). | Posted | Mean | 90% Confidence Interval | Injections/year | Day 1 through 96 weeks | Study Eyes | Study Eyes |
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| Secondary | Incidence of 2-step Improvement in Diabetic Retinopathy Severity Score (DRSS) in the Study Eye Over Time | Diabetic Retinopathy Severity Score was determined by the Central Reading Center using ultra-wide field color retinopathy fundus photography. The score represents a comprehensive evaluation of retinal health, including the presence of microaneurysms, hemorrhages, and other abnormalities in the retina of the study eye. The score ranges from 10 to 85 and is divided into 13-steps used to classify increasing diabetic retinopathy severity (with higher scored indicating more advanced stages of Diabetic Retinopathy). In this endpoint a 2-step improvement indicates an improvement in a participant across 2 steps of the 13-step scale. | The Modified Intent to Treat population (mITT) was analyzed for this endpoint (mITT population includes all randomized participants treated on both Day 1 [Aflibercept or Sham] and Day 8 [Ixo-vec or Sham]). Only mITT participants whose Baseline Score permitted a ≥ 2 step DRSS improvement were eligible for this analysis. The incidence of 2-step improvement in DRSS score over time at Week 96 is presented. | Posted | Count of Participants | Participants | From Day 1 through 96 weeks |
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| Secondary | Incidence of 3-step Improvement in DRSS (Diabetic Retinopathy Severity Score) in the Study Eye Over Time | Diabetic Retinopathy Severity Score was determined by the Central Reading Center using ultra-wide field color retinopathy fundus photography. The score represents a comprehensive evaluation of retinal health, including the presence of microaneurysms, hemorrhages, and other abnormalities in the retina of the study eye. The score ranges from 10 to 85 and is divided into 13-steps used to classify increasing diabetic retinopathy severity (with higher scored indicating more advanced stages of Diabetic Retinopathy). In this endpoint a 3-step improvement indicates an improvement in a participant across 3 steps of the 13-step scale. | The Modified Intent to Treat population (mITT) was analyzed for this endpoint (mITT population includes all randomized participants treated on both Day 1 [Aflibercept or Sham] and Day 8 [Ixo-vec or Sham]). Only mITT participants whose Baseline Score permitted a ≥3 step DRSS improvement were eligible for this analysis. The incidence of 3-step improvement in DRSS score over time at Week 96 is presented. Visits with a 3-step or greater improvement in DRSS were considered separate events. | Posted | Count of Participants | Participants | From Day 1 through 96 weeks |
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| Secondary | Incidence of 2-step Worsening in DRSS (Diabetic Retinopathy Severity Score) in the Study Eye Over Time | Diabetic Retinopathy Severity Score was determined by the Central Reading Center using ultra-wide field color retinopathy fundus photography. The score represents a comprehensive evaluation of retinal health, including the presence of microaneurysms, hemorrhages, and other abnormalities in the retina of the study eye. The score ranges from 10 to 85 and is divided into 13-steps used to classify increasing diabetic retinopathy severity (with higher scored indicating more advanced stages of Diabetic Retinopathy). In this endpoint a 2-step worsening indicates a worsening across 2 steps of the 13-step scale. Note: 2-step worsening in DRSS was observed in 2 participants in both the control arm and the ADVM-022 6E11 vg/eye arm. These participants experienced ocular adverse events which may have contributed, at least in part, to the worsening in DRSS. This included one participant in the ADVM-022 6E11 vg/eye arm who had a SUSAR of Hypotony of eye (secondary to intraocular inflammation). | The Modified Intent to Treat population (mITT) was analyzed for this endpoint (mITT population includes all randomized participants who received study treatment at both Day 1 [Aflibercept or Sham] and Day 8 [Ixo-vec or Sham]). The incidence of 2-step worsening in DRSS score over time at Week 96 is presented. Visits with a 2-step or greater worsening in DRSS were considered separate events. | Posted | Count of Participants | Participants | From Day 1 through 96 weeks |
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| Secondary | Incidence of 3-step Worsening in DRSS (Diabetic Retinopathy Severity Score) in the Study Eye Over Time | Diabetic Retinopathy Severity Score was determined by the Central Reading Center using ultra-wide field color retinopathy fundus photography. The score represents a comprehensive evaluation of retinal health, including the presence of microaneurysms, hemorrhages, and other abnormalities in the retina of the study eye. The score ranges from 10 to 85 with higher scored indicating more advanced stages of Diabetic Retinopathy. The incidence of 3-step worsening in DRSS score over time at Week 96 is presented. Visits with a 3-step or greater worsening in DRSS were considered separate events. Note: 3-step worsening in DRSS was observed in one participant each in the control arm and the ADVM-022 6E11 vg/eye arm. Both participants experienced ocular adverse events which may have contributed, at least in part, to the worsening in DRSS. This included one participant in the ADVM-022 6E11 vg/eye arm who had a SUSAR of Hypotony of eye (secondary to intraocular inflammation). | The Modified Intent to Treat population (mITT) was analyzed for this endpoint (mITT population includes all randomized participants who received study treatment at both Day 1 [Aflibercept or Sham] and Day 8 [Ixo-vec or Sham]). | Posted | Count of Participants | Participants | From Day 1 through 96 weeks |
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| Secondary | Occurrence of Any Vision Threatening Complications in the Study Eye (Anterior Segment Neovascularization, Vitreous Hemorrhage, or Any Other High-risk Proliferative DR, or Tractional Retinal Detachment) Over Time Through Week 96 | Occurrence of any vision threatening complication over time though 96 weeks. Results present the incidence of participants who experienced "Any Vision Threatening Complications" (defined as any Vitreous Haemorrhage adverse event (AE), Anterior Segment Neovascularization AE, High-risk proliferative DR (defined as DSSR >= 71), or Tractional Retinal Detachment AE) in the study eye from Day 1 through 96 weeks. Note: AEs of Vitreous Haemorrhage and High-risk proliferative DR were reported in 1 participant in the control arm and in 2 separate participants in the 6E11 vg/eye arm. No AE of Tractional Retinal Detachment or Anterior Segment Neovascularization occurred. | The Modified Intent to Treat population (mITT) was analyzed for this endpoint (mITT population includes all randomized participants who received study treatment at both Day 1 [Aflibercept or Sham] and Day 8 [Ixo-vec or Sham]). | Posted | Count of Participants | Participants | From Day 1 through 96 weeks |
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| Secondary | Incidence of CST <300 μm Over Time Through Week 96 in the Study Eye | Central subfield thickness is a measurement of the thickness of the retina in a circular area around the fovea. Incidence of participants with Central subfield thickness of less than 300 μm over time in the study eye through Week 96 is presented. | The Modified Intent to Treat population (mITT) was analyzed for this endpoint (mITT population includes all randomized participants who received study treatment at both Day 1 [Aflibercept or Sham] and Day 8 [Ixo-vec or Sham]). Incidence through last visit represent the last visit through Week 96 with non-missing CST data. | Posted | Count of Participants | Participants | Day 1 through 96 weeks |
|
Adverse event data are presented from study treatment on Day 1 through Week 96.
The modified Intent to Treat (mITT) Population was analyzed - included all participants who received treatment on Day 1 (Aflibercept or Sham) and Day 8 (Ixo-vec or Sham) and data summarized based on treatments participants received on Days 1 and 8. The mITT population does not include 2 participants who were discontinued prior to Day 8. Neither of these participants reported any adverse events. Ocular adverse events are presented for the Study Eye only (no SAEs were reported in the fellow eye).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ADVM-022 6E11 vg/Eye | 6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 6E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator | 0 | 12 | 9 | 12 | 12 | 12 |
| EG001 | ADVM-022 2E11 vg/Eye | 2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 2E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator | 1 | 13 | 8 | 13 | 13 | 13 |
| EG002 | Aflibercept + Sham | Aflibercept 2mg IVT Aflibercept: Commercially available Active Comparator | 0 | 9 | 4 | 9 | 9 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery stenosis | Cardiac disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular SAEs are presented for the Study Eye only. |
|
| Cataract subcapsular | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular SAEs are presented for the Study Eye only. |
|
| Visual impairment | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular SAEs are presented for the Study Eye only. |
|
| Hypotony of eye | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular SAEs are presented for the Study Eye only. |
|
| Iridocyclitis | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular SAEs are presented for the Study Eye only. |
|
| Angle closure glaucoma | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular SAEs are presented for the Study Eye only. |
|
| Cataract nuclear | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular SAEs are presented for the Study Eye only. |
|
| Choroidal effusion | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular SAEs are presented for the Study Eye only. |
|
| Cystoid macular oedema | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular SAEs are presented for the Study Eye only. |
|
| Vitritis | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular SAEs are presented for the Study Eye only. |
|
| Diabetic gastroparesis | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Cholecystitis infective | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Osteomyelitis acute | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Carotid artery occlusion | Nervous system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Diabetic neuropathy | Nervous system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Peripheral artery occlusion | Vascular disorders | MedDRA Version 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Abdominal lymphadenopathy | Blood and lymphatic system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Iridocyclitis | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Anterior chamber cell | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Iris transillumination defect | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Iris adhesions | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Ocular hypertension | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Diabetic retinal oedema | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Pigment dispersion syndrome | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Cataract | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Keratic precipitates | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Vitreous floaters | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Cataract subcapsular | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Iris hyperpigmentation | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Iritis | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Uveitis | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Decrease in intraocular pressure | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Corneal striae | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Punctate keratitis | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Anterior chamber flare | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Lenticular pigmentation | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Vitreous detachment | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Corneal oedema | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Flat anterior chamber of eye | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Iris atrophy | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Mydriasis | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Posterior capsule opacification | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Vitreous haemorrhage | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Vitreous opacities | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Ocular hypotension | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Vision blurred | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Cataract nuclear | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Chalazion | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Ciliary body disorder | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Conjunctivitis allergic | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Corneal erosion | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Diabetic retinopathy | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Epiretinal membrane | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Eyelid margin crusting | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Eyelid ptosis | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Foreign body sensation in eyes | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Hypotony | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Hypotony maculopathy | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| IOP 5mmHG Post injection | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Narrow anterior chamber angle | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Ocular discomfort | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Periorbital oedema | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Periorbital pain | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Photophobia | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Swelling of eyelid | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Visual impairment | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Vitreal cells | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Vitreoretinal traction syndrome | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Vitreous haze | Eye disorders | MedDRA Version 25.1 | Systematic Assessment | Ocular AEs are presented for the Study Eye only. |
|
| Toothache | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Gallbladder polyp | Hepatobiliary disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Eye infection | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Urinary tract infection staphylococcal | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Systematic Assessment |
| |
| Corneal abrasion | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Systematic Assessment |
| |
| Hyphaema | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA Version 25.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Degenerative bone disease | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Adrenal adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | Systematic Assessment |
| |
| Diabetic neuropathy | Nervous system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Cerebral ventricle dilatation | Nervous system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA Version 25.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Renal atrophy | Renal and urinary disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Renal cyst | Renal and urinary disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Pelvic fluid collection | Reproductive system and breast disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Lung opacity | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Aortic arteriosclerosis | Vascular disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA Version 25.1 | Systematic Assessment |
| |
| Gastrooesophageal hypot disease | Gastrointestinal disorders | MedDRA Version 25.1 | Systematic Assessment |
|
Although this study was initiated as a randomized, double-masked study, the Sponsor and the independent data monitoring committee agreed to unmask the study following an ocular suspected unexpected serious adverse reaction (SUSAR) of Hypotony and concerns regarding the appropriate management of ocular inflammation and hypotony. All participants had reached the 12-week assessment at the time of unmasking.
Investigators agreed to postponement of single-site study publications until after publication of all multi-center study results, until notification by the Sponsor that a multi-center publication is not planned, or until eighteen (18) months after final database lock.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Medical Director | Adverum Biotechnologies | 650-656-9323 | clinicaltrials@adverum.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 28, 2022 | Jun 17, 2025 | SAP_003.pdf |
Not provided
| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| D001766 | Blindness |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C533178 | aflibercept |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Aflibercept 2mg IVT
Aflibercept: Commercially available Active Comparator
|
|
Aflibercept 2mg IVT
Aflibercept: Commercially available Active Comparator
|
|
| Aflibercept + Sham |
Aflibercept 2mg IVT Aflibercept: Commercially available Active Comparator |
|
|
Aflibercept 2mg IVT Aflibercept: Commercially available Active Comparator |
|
|
| OG002 | Aflibercept + Sham | Aflibercept 2mg IVT Aflibercept: Commercially available Active Comparator |
|
|
| ADVM-022 2E11 vg/Eye |
2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 2E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator |
| OG002 | Aflibercept + Sham | Aflibercept 2mg IVT Aflibercept: Commercially available Active Comparator |
|
|
| OG001 | ADVM-022 2E11 vg/Eye | 2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 2E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator |
| OG002 | Aflibercept + Sham | Aflibercept 2mg IVT Aflibercept: Commercially available Active Comparator |
|
|
| OG001 | ADVM-022 2E11 vg/Eye | 2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 2E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator |
| OG002 | Aflibercept + Sham | Aflibercept 2mg IVT Aflibercept: Commercially available Active Comparator |
|
|
| OG001 | ADVM-022 2E11 vg/Eye | 2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 2E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator |
| OG002 | Aflibercept + Sham | Aflibercept 2mg IVT Aflibercept: Commercially available Active Comparator |
|
|
2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT 2E11 vg/eye of ADVM-022: ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept Aflibercept: Commercially available Active Comparator |
| OG002 | Aflibercept + Sham | Aflibercept 2mg IVT Aflibercept: Commercially available Active Comparator |
|
|
| OG002 |
| Aflibercept + Sham |
Aflibercept 2mg IVT Aflibercept: Commercially available Active Comparator |
|
|