ClinicalTrials.gg
RecruitingNCT07812090QUELL-DMEUpdated Oct 27, 2026

A Randomized, Phase 2 Study of Oral BGE-102 in Participants With Center-Involved Diabetic Macular Edema

A Phase 2 interventional study of Oral BGE-102 and Oral Placebo Matching BGE-102 in Diabetic Macular Edema (DME), sponsored by BioAge Labs, Inc.. Recruiting at 16 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by BioAge Labs, Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Updated Oct 27, 202615 sites addedGo to Updates ↓

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Phase
Phase 2
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 33 studies testing bevacizumab in Diabetic Retinopathy — 2 open to participants now, 2 under way, 1 of them phase 3. Bevacizumab · Diabetic Retinopathy.

Planned enrollment
Largest of 28
180 · median 30
Started
2026
the only one that year
Phase 2
7 of 33
1 open now
Registered
33rd of 33
by date
Lead sponsor
1 of 33
BioAge Labs, Inc.

Among the 33 studies testing bevacizumab in Diabetic Retinopathy, this one has the largest planned enrollment of the 28 interventional ones that give a count, is the only one that started in 2026, is one of 7 in phase 2, and was the 33rd registered.

Diabetic Retinopathy

778 studies on the registry are indexed under Diabetic Retinopathy; 142 are open to participants now.

Browse Diabetic Retinopathy studies →

Open to participants now

2 of the 33 studies testing bevacizumab in Diabetic Retinopathy are open now, in 2 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

About bevacizumab

Bevacizumab: first FDA approval 2004 (AVASTIN), first EMA approval 2005. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 92 Diabetic Retinopathy studies recruiting now, 60 (65%) set no upper age limit and 10 (11%) stop at 75 or younger; 8 take children under 18; 29 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 33 studies testing bevacizumab in Diabetic Retinopathy, or all of them as a file.
02

Study 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. 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.
03

Conditions studied

  • Diabetic Macular Edema (DME)

Browse trials for

Keywords

  • Diabetic Macular Edema
  • Diabetic Retinopathy
  • BGE-102
  • BioAge
  • NLRP3
  • Center-Involved
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • 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 , if applicable

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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 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
Terms in these criteria, in plain language(3)

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.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    Arm A: BGE-102 Monotherapy

    BGE-102 Capsules dosed once daily in combination with Sham intravitreal injection delivered every 4 weeks

    Drug: Oral BGE-102 · Other: Sham

  • Experimental
    Arm B: BGE-102 and anti-VEGF Combination Therapy

    BGE-102 Capsules dosed once daily in combination with anti-VEGF intravitreal injection delivered every 4 weeks

    Drug: Oral BGE-102 · Drug: Anti-VEGF

  • Active comparator
    Arm C: anti-VEGF Monotherapy

    Placebo Capsules dosed once daily in combination with anti-VEGF intravitreal injection delivered every 4 weeks

    Drug: Oral Placebo Matching BGE-102 · Drug: Anti-VEGF

Interventions

  • DrugOral BGE-102

    Capsules

  • DrugOral Placebo Matching BGE-102

    Capsules

  • intravitreal injection

  • OtherSham

    intravitreal injection

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Week 12

Secondary outcomes

  1. Incidence of serious adverse events (SAEs)

    Time frame: Up to Week 16

  2. Incidence of treatment-emergent adverse events (TEAEs)

    Time frame: Up to Week 16

07

Study locations

16 of 16 sites recruiting
  • Site 104
    Bakersfield, California 93309, United States
    Recruiting
  • Site 105
    Glendale, California 91204, United States
    Recruiting
  • Site 118
    Mountain View, California 94040, United States
    Recruiting
  • Site 128
    Fort Myers, Florida 33912, United States
    Recruiting
  • Site 113
    South Miami, Florida 33143, United States
    Recruiting
  • Site 119
    West Monroe, Louisiana 71291, United States
    Recruiting
  • Site 117
    Cary, North Carolina 27511, United States
    Recruiting
  • Site 116
    Wake Forest, North Carolina 27587, United States
    Recruiting
  • Site 101
    Ladson, South Carolina 29456, United States
    Recruiting
  • Site 111
    Abilene, Texas 79606, United States
    Recruiting
  • Site 129
    Austin, Texas 78750, United States
    Recruiting
  • Site 130
    Houston, Texas 77030, United States
    Recruiting
  • Site 125
    Laredo, Texas 78041, United States
    Recruiting
  • Site 106
    McAllen, Texas 78503, United States
    Recruiting
  • Site 110
    San Antonio, Texas 78240, United States
    Recruiting
  • Site 108
    The Woodlands, Texas 77384, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Nov 2027, 15 months after the start.

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 planned 15 months is below 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.

Registered
Sep 4, 2026
First posted
Sep 10, 2026
StartActual
Aug 21, 2026
Primary completionEst.
Nov 2027
CompletionEst.
Dec 2027
Last update
Oct 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
15 sites added
Show 15 added (15 United States)
  • Site 104 · Bakersfield, United States
  • Site 105 · Glendale, United States
  • Site 118 · Mountain View, United States
  • Site 128 · Fort Myers, United States
  • Site 113 · South Miami, United States
  • Site 119 · West Monroe, United States
  • Site 117 · Cary, United States
  • Site 116 · Wake Forest, United States
  • Site 101 · Ladson, United States
  • Site 111 · Abilene, United States
  • Site 129 · Austin, United States
  • Site 130 · Houston, United States
  • Site 125 · Laredo, United States
  • Site 110 · San Antonio, United States
  • Site 108 · The Woodlands, United States
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    15 sites added
    Show 15 added (15 United States)
    • Site 104 · Bakersfield, United States
    • Site 105 · Glendale, United States
    • Site 118 · Mountain View, United States
    • Site 128 · Fort Myers, United States
    • Site 113 · South Miami, United States
    • Site 119 · West Monroe, United States
    • Site 117 · Cary, United States
    • Site 116 · Wake Forest, United States
    • Site 101 · Ladson, United States
    • Site 111 · Abilene, United States
    • Site 129 · Austin, United States
    • Site 130 · Houston, United States
    • Site 125 · Laredo, United States
    • Site 110 · San Antonio, United States
    • Site 108 · The Woodlands, United States
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07812090
Lead sponsor
BioAge Labs, Inc.
Responsible party
Sponsor
First posted
Sep 10, 2026
Start date
Aug 21, 2026
Primary completion
Nov 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Oct 27, 2026

Study contacts

Central Recruiting
Contact
bge102-004_inquiry@bioagelabs.com
866-331-7781

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Bevacizumab

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