Health TrialsbyHealthPanel

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

ConditionDiabetic Macular Edema (DME)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBioAge Labs, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Oral BGE-102

    Drug

    Capsules

  • Oral Placebo Matching BGE-102

    Drug

    Capsules

  • Anti-VEGF

    Drug

    intravitreal injection

  • Sham

    Other intervention

    intravitreal injection

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: Arm A: BGE-102 MonotherapyExperimental treatment 2 interventions
Group B: Arm B: BGE-102 and anti-VEGF Combination TherapyExperimental treatment 2 interventions
Group C: Arm C: anti-VEGF MonotherapyActive comparator 2 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BioAge Labs, Inc.

Lead sponsor

Source ClinicalTrials.gov
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