Diabetic Macular Edema (DME)Phase 2QUELL-DMENCT07812090
A Randomized, Phase 2 Study of Oral BGE-102 in Participants With Center-Involved Diabetic Macular Edema
A Phase 2 study testing Oral BGE-102 and Anti-VEGF in people with Diabetic Macular Edema (DME), run by BioAge Labs, Inc. at 16 sites in United States.
Trial summary
The purpose of this study is to learn about the effects of BGE-102 on change in vision in participants with center-involved diabetic macular edema (CI-DME). BGE-102 decreases inflammation which may improve vision or slow the progression of vison loss in those with CI-DME. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Macular Edema (DME)
- What is being tested?
- Oral BGE-102 and Anti-VEGF
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 16 sitesUnited States
- Study dates
- 21 Aug 2026to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18-75 years of age
- Type 1 or Type 2 Diabetes diagnosis
- Diabetic Macular Edema (DME) affecting the center of vision
- Study Eye may be treatment naïve (never received treatment) or previously treated and if previously treated, meets washout requirements
- Acceptable Vision as measured by an eye chart
- Visual Acuity and retinal thickness as measured by an eye scan, results meeting eligibility criteria
- Willing to use birth control, if applicable
Who cannot join
- Significant ocular disease, condition, or prior ocular treatment and/ or procedure that could affect vision, study assessments, or participant safety, including failure to meet required treatment washout periods
- Macular edema in the study eye due to causes other than DME, such as retinal vein occlusion, uveitis, neovascular age-related macular degeneration
- Significant macular ischemia in the study eye that would limit visual improvement as assessed by the Investigator and confirmed by the Reading Center
- Uncontrolled diabetes
- Uncontrolled blood pressure
- Medically unstable cardiac conditions and/or medically important ECG abnormalities.
- Relevant medical or psychiatric condition(s) that put the participant at risk or will make implementation of the protocol or interpretation of the study difficult.
- Women who are pregnant or nursing
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
United States16 sites, 16 recruiting
- Recruiting
Site 111
Abilene, Texas, 79606
Central Recruiting, 866-331-7781, bge102-004_inquiry@bioagelabs.com
- Recruiting
Site 129
Austin, Texas, 78750
Central Recruiting, 866-331-7781, bge102-004_inquiry@bioagelabs.com
- Recruiting
Site 104
Bakersfield, California, 93309
Central Recruiting, 866-331-7781, bge102-004_inquiry@bioagelabs.com
- Recruiting
Site 117
Cary, North Carolina, 27511
Central Recruiting, 866-331-7781, bge102-004_inquiry@bioagelabs.com
- Recruiting
Site 128
Fort Myers, Florida, 33912
Central Recruiting, 866-331-7781, bge102-004_inquiry@bioagelabs.com
- Recruiting
Site 105
Glendale, California, 91204
Central Recruiting, 866-331-7781, bge102-004_inquiry@bioagelabs.com
- Recruiting
Site 130
Houston, Texas, 77030
Central Recruiting, 866-331-7781, bge102-004_inquiry@bioagelabs.com
- Recruiting
Site 101
Ladson, South Carolina, 29456
Central Recruiting, 866-331-7781, bge102-004_inquiry@bioagelabs.com
- Recruiting
Site 125
Laredo, Texas, 78041
Central Recruiting, 866-331-7781, bge102-004_inquiry@bioagelabs.com
- Recruiting
Site 106
McAllen, Texas, 78503
Central Recruiting, 866-331-7781, bge102-004_inquiry@bioagelabs.com
- Recruiting
Site 118
Mountain View, California, 94040
Central Recruiting, 866-331-7781, bge102-004_inquiry@bioagelabs.com
- Recruiting
Site 110
San Antonio, Texas, 78240
Central Recruiting, 866-331-7781, bge102-004_inquiry@bioagelabs.com
- Recruiting
Site 113
South Miami, Florida, 33143
Central Recruiting, 866-331-7781, bge102-004_inquiry@bioagelabs.com
- Recruiting
Site 108
The Woodlands, Texas, 77384
Central Recruiting, 866-331-7781, bge102-004_inquiry@bioagelabs.com
- Recruiting
Site 116
Wake Forest, North Carolina, 27587
Central Recruiting, 866-331-7781, bge102-004_inquiry@bioagelabs.com
- Recruiting
Site 119
West Monroe, Louisiana, 71291
Central Recruiting, 866-331-7781, bge102-004_inquiry@bioagelabs.com
About this study
Official title: A Randomized, Double-Masked, Multicenter Phase 2 Study Evaluating the Efficacy, Safety, and Tolerability of Oral BGE-102 as Mono- and Combination Therapy in Participants With Center-Involved Diabetic Macular Edema
The purpose of this study is to learn about the effects of BGE-102 on change in vision in participants with center-involved diabetic macular edema (CI-DME). BGE-102 decreases inflammation which may improve vision or slow the progression of vison loss in those with CI-DME. Participants will be randomized to one of 3 arms and receive either BGE-102 in combination with an anti-vascular endothelial growth factor (anti-VEGF) drug, BGE-102 in combination with sham injection, or BGE-102 placebo in combination with an anti-VEGF drug. This study will also evaluate safety and tolerability of BGE-102.
Read the detailed description
The purpose of this study is to assess the efficacy and safety of oral once a day (QD) dosing of BGE-102 alone or BGE-102 in combination with an anti-VEGF drug compared to anti-VEGF alone in participants with CI-DME on ocular parameters over 12 weeks of treatment.
Study details include:
- The study duration will be approximately 20 weeks (5 months) including the following study periods: screening (up to 4 weeks), treatment (12 weeks), and post treatment follow-up (4 weeks).
- The visit frequency will be every 2 weeks for the first 4 weeks of the treatment period and every 4 weeks thereafter up to Week 16.
- The treatment duration will be up to 12 weeks. BGE-102 will be given active, once daily capsules, or placebo, once daily capsules, in combination with anti-VEGF every four weeks intravitreal injection or sham injection for the entire 12-week treatment period.
- Conditions
- Diabetic Macular Edema (DME)
- Being tested
- Oral BGE-102, Oral Placebo Matching BGE-102, Anti-VEGF, Sham
- Keywords
- Diabetic Macular Edema, Diabetic Retinopathy, BGE-102, BioAge, NLRP3, Center-Involved
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral BGE-102Drug
Capsules
Oral Placebo Matching BGE-102Drug
Capsules
Anti-VEGFDrug
intravitreal injection
ShamOther
intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| Arm A: BGE-102 Monotherapy | Experimental | BGE-102 Capsules dosed once daily in combination with Sham intravitreal injection delivered every 4 weeks Receives: Drug: Oral BGE-102; Other: Sham |
| Arm B: BGE-102 and anti-VEGF Combination Therapy | Experimental | BGE-102 Capsules dosed once daily in combination with anti-VEGF intravitreal injection delivered every 4 weeks Receives: Drug: Oral BGE-102; Drug: Anti-VEGF |
| Arm C: anti-VEGF Monotherapy | Active comparator | Placebo Capsules dosed once daily in combination with anti-VEGF intravitreal injection delivered every 4 weeks Receives: Drug: Oral Placebo Matching BGE-102; Drug: Anti-VEGF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Best Corrected Visual Acuity (BCVA)
Change from Baseline in BCVA as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) in the Study Eye
Measured: Week 12
Secondary outcomes (2)
Incidence of serious adverse events (SAEs)
Measured: Up to Week 16
Incidence of treatment-emergent adverse events (TEAEs)
Measured: Up to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start21 Aug 2026
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular Edema (DME)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioAge Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812090
- Sponsor's protocol ID
- BGE-102-004
- Acronym
- QUELL-DME
- Status last verified
- Oct 2026
- First submitted
- 4 Sep 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Masked, Multicenter Phase 2 Study Evaluating the Efficacy, Safety, and Tolerability of Oral BGE-102 as Mono- and Combination Therapy in Participants With Center-Involved Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT07812090
- Acronym / sponsor ID
- QUELL-DME / BGE-102-004
- Conditions
- Diabetic Macular Edema (DME)
- Keywords
- Diabetic Macular Edema, Diabetic Retinopathy, BGE-102, BioAge, NLRP3, Center-Involved
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- BioAge Labs, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Aug 2026 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn about the effects of BGE-102 on change in vision in participants with center-involved diabetic macular edema (CI-DME). BGE-102 decreases inflammation which may improve vision or slow the progression of vison loss in those with CI-DME. Participants will be randomized to one of 3 arms and receive either BGE-102 in combination with an anti-vascular endothelial growth factor (anti-VEGF) drug, BGE-102 in combination with sham injection, or BGE-102 placebo in combination with an anti-VEGF drug. This study will also evaluate safety and tolerability of BGE-102.
Detailed description
The purpose of this study is to assess the efficacy and safety of oral once a day (QD) dosing of BGE-102 alone or BGE-102 in combination with an anti-VEGF drug compared to anti-VEGF alone in participants with CI-DME on ocular parameters over 12 weeks of treatment.
Study details include:
- The study duration will be approximately 20 weeks (5 months) including the following study periods: screening (up to 4 weeks), treatment (12 weeks), and post treatment follow-up (4 weeks).
- The visit frequency will be every 2 weeks for the first 4 weeks of the treatment period and every 4 weeks thereafter up to Week 16.
- The treatment duration will be up to 12 weeks. BGE-102 will be given active, once daily capsules, or placebo, once daily capsules, in combination with anti-VEGF every four weeks intravitreal injection or sham injection for the entire 12-week treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: BGE-102 Monotherapy | Experimental | Drug: Oral BGE-102, Other: ShamBGE-102 Capsules dosed once daily in combination with Sham intravitreal injection delivered every 4 weeks |
| Arm B: BGE-102 and anti-VEGF Combination Therapy | Experimental | Drug: Oral BGE-102, Drug: Anti-VEGFBGE-102 Capsules dosed once daily in combination with anti-VEGF intravitreal injection delivered every 4 weeks |
| Arm C: anti-VEGF Monotherapy | Active comparator | Drug: Oral Placebo Matching BGE-102, Drug: Anti-VEGFPlacebo Capsules dosed once daily in combination with anti-VEGF intravitreal injection delivered every 4 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults 18-75 years of age
- Type 1 or Type 2 Diabetes diagnosis
- Diabetic Macular Edema (DME) affecting the center of vision
- Study Eye may be treatment naïve (never received treatment) or previously treated and if previously treated, meets washout requirements
- Acceptable Vision as measured by an eye chart
Key exclusion criteria (8 listed)
- Significant ocular disease, condition, or prior ocular treatment and/ or procedure that could affect vision, study assessments, or participant safety, including failure to meet required treatment washout periods
- Macular edema in the study eye due to causes other than DME, such as retinal vein occlusion, uveitis, neovascular age-related macular degeneration
- Significant macular ischemia in the study eye that would limit visual improvement as assessed by the Investigator and confirmed by the Reading Center
- Uncontrolled diabetes
- Uncontrolled blood pressure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral BGE-102Capsules | Drug | Arm A: BGE-102 Monotherapy, Arm B: BGE-102 and anti-VEGF Combination Therapy |
| Oral Placebo Matching BGE-102Capsules | Drug | Arm C: anti-VEGF Monotherapy |
| Anti-VEGFintravitreal injection | Drug | Arm B: BGE-102 and anti-VEGF Combination Therapy, Arm C: anti-VEGF Monotherapy |
| Shamintravitreal injection | Other | Arm A: BGE-102 Monotherapy |
Primary outcome
Change in Best Corrected Visual Acuity (BCVA)
Time frame: Week 12
Change from Baseline in BCVA as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) in the Study Eye
2 secondary outcomes
Incidence of serious adverse events (SAEs)
Time frame: Up to Week 16
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Up to Week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral BGE-102 and Anti-VEGF in people with Diabetic Macular Edema (DME), run by BioAge Labs, Inc. at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Central Recruiting (866-331-7781, bge102-004_inquiry@bioagelabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Best Corrected Visual Acuity (BCVA) (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.