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New treatment option for Macular Edema
Official title A Study to Test Whether BI 1815368 Helps People With an Eye Condition Called Diabetic Macular Edema
ClinicalTrials.gov ID: NCT06962839
What this study is testing
What is BI 1815368?
BI 1815368 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for macular edema.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is open to adults 18 and older with an eye condition called diabetic macular edema. People are required to have a specific type of diabetic macular edema called centre-involved diabetic macular edema (CI-DME) to take part.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 1 year
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥18 years of age
- Diagnosis of diabetes mellitus (DM) (type 1 or type 2), Haemoglobin A1C (HbA1c) \<12% treated with stable medication for at least 30 days prior to...
- Centre-involved diabetic macular edema (CI-DME) confirmed on spectral domain optical coherence tomography (SD-OCT) with central subfield foveal...
- Best corrected visual acuity (BCVA) visual acuity Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye between 24 and 78...
You likely can't join if
- Macular edema considered to be due to other causes than CI-DME in the study eye
- Proliferative diabetic retinopathy or iris neovascularisation (including the anterior chamber angle) in the study eye
- Any intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) treatment within 4 months before Day 1 (other than faricimab or aflibercept...
- Any history of panretinal photocoagulation, macular laser photocoagulation, vitreoretinal surgery, IVT or periocular corticosteroid treatment (within...
- Active ocular inflammation of any history of intraocular inflammation within 1 year
- Aphakia or total absence of the posterior capsule; Yttrium aluminium garnet (YAG) laser capsulotomy in the study eye is permitted if more than 2...
The study team makes the final eligibility decision.
Where it's taking place
- Arcadia, California, United States
- Huntington Beach, California, United States
- Modesto, California, United States
- Pasadena, California, United States
- Poway, California, United States
- San Francisco, California, United States
- Lakewood, Colorado, United States
- Pompano Beach, Florida, United States
- Winter Haven, Florida, United States
- Carmel, Indiana, United States
- Kansas City, Kansas, United States
- Hagerstown, Maryland, United States
- Reno, Nevada, United States
- Wake Forest, North Carolina, United States
- Cleveland, Ohio, United States
- Eugene, Oregon, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- Dallas, Texas, United States
- Southlake, Texas, United States
+ 48 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Arcadia, California, United States; Huntington Beach, California, United States; Modesto, California, United States; Pasadena, California, United States; Poway, California, United States; San Francisco, California, United States and 62 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.