Diabetic Macular EdemaPhase 2NCT07383701
Lactiplantibacillus Plantarum 299v Probiotic Supplementation in Patients With Diabetic Macular Edema
A Phase 2 study testing Lactobacillus plantarum 299v in people with Diabetic Macular Edema, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
Trial summary
This pilot prospective, interventional, longitudinal study, aims to evaluate the potential benefits of the probiotic supplement Lactobacillus plantarum 299v in patients with diabetic macular edema (DME). The study seeks to address the following questions: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Lactobacillus plantarum 299v
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2026to 1 Sep 2027
- Phase
- Phase 2
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of at least 18 years, presence of DME at the current clinical visit
Who cannot join
- Patients with contraindication to probiotic supplement (e.g. prior allergy or GI intolerance and any type of immunocompromised diseases).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mass Eye and Ear
Boston, Massachusetts, 02114
Demetrios G. Vavvas, MD PhD, 617-573-6874, Demetrios_Vavvas@meei.harvard.edu
Demetrios G. Vavvas, MD PhD
About this study
Official title: Lactiplantibacillus Plantarum 299v Probiotic Probiotic Supplementation in Patients With Diabetic Macular Edema
This pilot prospective, interventional, longitudinal study, aims to evaluate the potential benefits of the probiotic supplement Lactobacillus plantarum 299v in patients with diabetic macular edema (DME).
The study seeks to address the following questions:
Read more
- Does central macular thickness on optical coherence tomography decrease after 4 months of supplementation?
- Is visual acuity improved at 1, 2, 3, and 4 months following initiation of supplementation?
- Is the number of anti-VEGF injections reduced following initiation of supplementation?
Outcomes will be compared to a control group, using historic retrospective data.
Participants will take Lactobacillus plantarum 299v orally twice daily for four months.
Read the detailed description
Study Design: Prospective open label longitudinal interventional study with oral probiotic supplement Lactobacillus plantarum.
Inclusion criteria: Age of at least 18 years, presence of DME at the current clinical visit
Exclusion criteria: Patients with contraindication to probiotic supplement (e.g. prior allergy or GI intolerance and any type of immunocompromised diseases).
Eligible individuals (patients at least 18 years old with diabetic macular
Participants: Patients with DME that belong in the following two groups:
- Group A: 12 Patients with mild DME and good visual acuity (<= 20/30) similar to DRCR network protocol V that do not need anti-VEGF injections as per standard clinical care.
- Group B: 12 Patients with DME that need anti-VEGF injections as per standard clinical care.
Intervention: Oral probiotic supplement L. plantarum 299v twice daily for 4 months for both groups.
Study outcomes:
- OCT with central macular thickness (CMT) at 1, 2, 3, 4-months follow-up.
- Visual Acuity at 1, 2, 3, 4-months follow-up.
- Number of anti VEGF injections.
In group A, the percentage of patients with a stability or improvement in DME as determined by a stability (+/- 9% of OCT CMT) or a reduction of DME (>= 30 microns or >= 10% decrease of CMT) from baseline will be measured. Secondary endpoints will be visual acuity and need for injection initiation during the 4 months.
In group B, the same outcomes as in group A will be measured. Furthermore, the number of injections group A over the course of 4 months will be evaluated.
Data from both groups will be compared to historical data available at the study site.
- Conditions
- Diabetic Macular Edema
- Being tested
- Lactobacillus plantarum 299v
- Keywords
- diabetic macular edema, Lactiplantibacillus plantarum 299v, probiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus plantarum 299vDrug
Lactiplantibacillus Plantarum 299v Probiotic Supplementation, Twice Daily, for 4 Months
| Study group | Role | What they receive |
|---|---|---|
| Main Arm - twice daily for 4 months | Experimental | This is the only arm in this study. All participants will receive 4 months of Lactobacillus plantarum supplementation. Receives: Drug: Lactobacillus plantarum 299v |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Macular Thickness
Central macular thickness (CMT) on optical coherence tomography
Measured: 1,2,3,4-months following supplement initiation
Secondary outcomes (2)
Best corrected visual acuity
Best corrected visual acuity
Measured: 1, 2, 3, 4-months following supplement initiation
Anti-VEGF Frequency
Number of anti VEGF injections
Measured: At 1,2,3,4-months following supplement initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start23 Jun 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetic Macular EdemaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demetrios Vavvas, Massachusetts Eye and Ear Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07383701
- Sponsor's protocol ID
- 2025P001157
- Status last verified
- Sep 2026
- First submitted
- 26 Jan 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Although data would be de-identified, the small sample size and single-center design increase the risk of re-identification. Therefore, results will be reported in aggregate only. There are no current plans for external sharing of IPD.
Publications
Senger DR, Li D, Jaminet SC, Cao S. Activation of the Nrf2 Cell Defense Pathway by Ancient Foods: Disease Prevention by Important Molecules and Microbes Lost from the Modern Western Diet. PLoS One. 2016 Feb 17;11(2):e0148042. doi: 10.1371/journal.pone.0148042. eCollection 2016.
PubMed 26885667Kensler TW, Wakabayashi N, Biswal S. Cell survival responses to environmental stresses via the Keap1-Nrf2-ARE pathway. Annu Rev Pharmacol Toxicol. 2007;47:89-116. doi: 10.1146/annurev.pharmtox.46.120604.141046.
PubMed 16968214Li JQ, Welchowski T, Schmid M, Letow J, Wolpers C, Pascual-Camps I, Holz FG, Finger RP. Prevalence, incidence and future projection of diabetic eye disease in Europe: a systematic review and meta-analysis. Eur J Epidemiol. 2020 Jan;35(1):11-23. doi: 10.1007/s10654-019-00560-z. Epub 2019 Sep 12.
PubMed 31515657