A Phase 2 interventional study of 6E11 vg/eye of ADVM-022 and 2E11 vg/eye of ADVM-022 in Diabetic Macular Edema and Diabetic Retinopathy, sponsored by Adverum Biotechnologies, Inc.. Completed at 14 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-10.
Sponsored by Adverum Biotechnologies, Inc. · Phase 2, Interventional, and Treatment
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.
778 studies on the registry are indexed under Diabetic Retinopathy; 142 are open to participants now.
This study's enrollment of 36 is below the median of 80 across 481 interventional studies indexed under Diabetic Retinopathy.
Browse Diabetic Retinopathy studies →Adverum Biotechnologies, Inc. is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT
Biological: 6E11 vg/eye of ADVM-022 · Biological: Aflibercept
2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT
Biological: 2E11 vg/eye of ADVM-022 · Biological: Aflibercept
Aflibercept 2mg IVT
Biological: Aflibercept
ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept
Also known as: AAV.7m8-aflibercept
ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept
Also known as: AAV.7m8-aflibercept
Commercially available Active Comparator
Also known as: Eylea
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.
Time frame: Day 1 through 96 weeks
Incidence of Ocular Adverse Events (AEs)
Incidence of ocular adverse events (AEs) through 96 weeks
Time frame: 96 weeks
Incidence of Non-ocular Adverse Events (AEs)
Incidence of non-ocular adverse events (AEs) through 96 weeks.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Day 1 through 96 weeks
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.
| Milestone | ADVM-022 6E11 vg/Eye | ADVM-022 2E11 vg/Eye | Aflibercept + Sham |
|---|---|---|---|
| Started | 13 | 13 | 10 |
| Modified itt (mitt) population | 12 | 13 | 9 |
| Completed | 12 | 9 | 7 |
| Not completed | 1 | 4 | 3 |
| Withdrew: Death | 0 | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 2 | 2 |
| Withdrew: Subject discontinued by the sponsor | 1 | 0 | 1 |
| Withdrew: Pre-existing medical condition | 0 | 1 | 0 |
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.
| Weeks | ADVM-022 6E11 vg/Eye | ADVM-022 2E11 vg/Eye | Aflibercept + Sham |
|---|---|---|---|
| Time to Worsening of DME Disease Activity in the Study Eye. | 82.1 (12.1 to NA) | 96.1 (20.6 to NA) | 19.1 (12.7 to 24.0) |
Incidence of ocular adverse events (AEs) through 96 weeks
| Participants | ADVM-022 6E11 vg/Eye | ADVM-022 2E11 vg/Eye | Aflibercept + Sham |
|---|---|---|---|
| Incidence of Ocular Adverse Events (AEs) | 12 | 13 | 9 |
Incidence of non-ocular adverse events (AEs) through 96 weeks.
| Participants | ADVM-022 6E11 vg/Eye | ADVM-022 2E11 vg/Eye | Aflibercept + Sham |
|---|---|---|---|
| Incidence of Non-ocular Adverse Events (AEs) | 9 | 9 | 7 |
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.
| micrometers | ADVM-022 6E11 vg/Eye | ADVM-022 2E11 vg/Eye | Aflibercept + Sham |
|---|---|---|---|
| Change From Baseline Central Subfield Thickness (CST) in Study Eye | -84.4 (-124.0 to -44.9) | -129.7 (-172.2 to -87.3) | -129.7 (-176.9 to -82.4) |
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.
| ETDRS letters | ADVM-022 6E11vg/Eye | ADVM-022 2E11 vg/Eye | Aflibercept + Sham |
|---|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) Score Over Time in the Study Eye | -11.9 (-20.7 to -3.2) | 10.1 (0.4 to 19.8) | 17.1 (7.1 to 27.0) |
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).
| Injections/year | ADVM-022 6E11 vg/Eye | ADVM-022 2E11 vg/Eye | Aflibercept + Sham |
|---|---|---|---|
| Frequency of Supplemental Aflibercept Injections (2 mg IVT) in the Study Eye Over Time During the Study | 1.001 (0.022 to 1.979) | 0.423 (0.055 to 0.792) | 5.54 (3.058 to 8.029) |
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.
| Participants | ADVM-022 6E11 vg/Eye | ADVM-022 2E11 vg/Eye | Aflibercept + Sham |
|---|---|---|---|
| Incidence of 2-step Improvement in Diabetic Retinopathy Severity Score (DRSS) in the Study Eye Over Time | 8 | 8 | 4 |
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.
| Participants | ADVM-022 6E11 vg/Eye | ADVM-022 2E11 vg/Eye | Aflibercept + Sham |
|---|---|---|---|
| Incidence of 3-step Improvement in DRSS (Diabetic Retinopathy Severity Score) in the Study Eye Over Time | 3 | 4 | 0 |
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).
| Participants | ADVM-022 6E11 vg/Eye | ADVM-022 2E11 vg/Eye | Aflibercept + Sham |
|---|---|---|---|
| Incidence of 2-step Worsening in DRSS (Diabetic Retinopathy Severity Score) in the Study Eye Over Time | 2 | 0 | 2 |
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).
| Participants | ADVM-022 6E11 vg/Eye | ADVM-022 2E11 vg/Eye | Aflibercept + Sham |
|---|---|---|---|
| Incidence of 3-step Worsening in DRSS (Diabetic Retinopathy Severity Score) in the Study Eye Over Time | 1 | 0 | 1 |
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.
| Participants | ADVM-022 6E11 vg/Eye | ADVM-022 2E11 vg/Eye | Aflibercept + Sham |
|---|---|---|---|
| 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 | 2 | 0 | 1 |
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.
| Participants | ADVM-022 6E11 vg/Eye | ADVM-022 2E11 vg/Eye | Aflibercept + Sham |
|---|---|---|---|
| Incidence of CST <300 μm Over Time Through Week 96 in the Study Eye | 8 | 6 | 4 |
Collected over Adverse event data are presented from study treatment on Day 1 through Week 96.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ADVM-022 6E11 vg/Eye | 0/12 (0%) | 9/12 (75%) | 12/12 (100%) |
| ADVM-022 2E11 vg/Eye | 1/13 (7.7%) | 8/13 (61.5%) | 13/13 (100%) |
| Aflibercept + Sham | 0/9 (0%) | 4/9 (44.4%) | 9/9 (100%) |
| Event | ADVM-022 6E11 vg/Eye | ADVM-022 2E11 vg/Eye | Aflibercept + Sham |
|---|---|---|---|
| CataractEye disorders | 4/12 | 2/13 | 1/9 |
| Visual impairmentEye disorders | 4/12 | 0/13 | 0/9 |
| Hypotony of eyeEye disorders | 3/12 | 0/13 | 0/9 |
| Cataract subcapsularEye disorders | 2/12 | 3/13 | 0/9 |
| IridocyclitisEye disorders | 2/12 | 0/13 | 0/9 |
| Acute kidney injuryRenal and urinary disorders | 1/12 | 2/13 | 1/9 |
| Cardiac failure acuteCardiac disorders | 0/12 | 0/13 | 1/9 |
| Cystoid macular oedemaEye disorders | 0/12 | 0/13 | 1/9 |
| Localised infectionInfections and infestations | 0/12 | 0/13 | 1/9 |
| Diabetic neuropathyNervous system disorders | 0/12 | 0/13 | 1/9 |
| Event | ADVM-022 6E11 vg/Eye | ADVM-022 2E11 vg/Eye | Aflibercept + Sham |
|---|---|---|---|
| Iris transillumination defectEye disorders | 8/12 | 4/13 | 0/9 |
| IridocyclitisEye disorders | 7/12 | 6/13 | 0/9 |
| Anterior chamber cellEye disorders | 6/12 | 4/13 | 3/9 |
| Iris adhesionsEye disorders | 6/12 | 5/13 | 0/9 |
| Ocular hypertensionEye disorders | 3/12 | 3/13 | 4/9 |
| Conjunctival haemorrhageEye disorders | 5/12 | 3/13 | 2/9 |
| Diabetic retinal oedemaEye disorders | 4/12 | 3/13 | 3/9 |
| CataractEye disorders | 4/12 | 2/13 | 0/9 |
| Vitreous floatersEye disorders | 4/12 | 1/13 | 0/9 |
| Cataract subcapsularEye disorders | 4/12 | 1/13 | 0/9 |
ITT (Intent to Treat) Population included all participants randomized to treatment. Participants were analyzed as randomized.
| Age, Continuous(Years) | ADVM-022 6E11 vg/Eye | ADVM-022 2E11 vg/Eye | Aflibercept + Sham | Total |
|---|---|---|---|---|
| Mean | 62.8 ± 5.94 | 60.5 ± 8.28 | 56.6 ± 5.68 | 60.3 ± 7.09 |
| Sex: Female, Male(Participants) | ADVM-022 6E11 vg/Eye | ADVM-022 2E11 vg/Eye | Aflibercept + Sham | Total |
|---|---|---|---|---|
| Female | 6 | 4 | 5 | 15 |
| Male | 7 | 9 | 5 | 21 |
| Ethnicity (NIH/OMB)(Participants) | ADVM-022 6E11 vg/Eye | ADVM-022 2E11 vg/Eye | Aflibercept + Sham | Total |
|---|---|---|---|---|
| Hispanic or Latino | 7 | 7 | 6 | 20 |
| Not Hispanic or Latino | 6 | 6 | 4 | 16 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | ADVM-022 6E11 vg/Eye | ADVM-022 2E11 vg/Eye | Aflibercept + Sham | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 0 | 1 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 3 | 0 | 4 |
| White | 11 | 10 | 10 | 31 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from May 2020 to primary completion in Nov 2022, 29 months.
Results were first posted in Jul 2025, 2 years 7 months after primary completion.
Of 30 industry-sponsored phase 2 interventional studies under Diabetic Retinopathy, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 37. This study's 29 months is close to that.
Counting every sponsor, half of 43 studies reached it within 31 months; a quarter within 17 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Adverum Biotechnologies, Inc.