vorolanib for Diabetic macular edema

Inclusion criteria

• {"criterion_text":"- Participants will be considered eligible for participation in the study if all of the following inclusion criteria are satisfied: 1. Male or female participants, ≥18 years of age.\n- 2. Participants with a diagnosis of diabetes mellitus (DM; Type 1 or Type 2), as defined by the World Health Organization (WHO) and/or American Diabetes Association. Must have stable DM for a minimum of 3 months prior to the Screening Visit, currently managed with use of oral antihyperglycemic agents, insulin, or other injectable drugs.\n- 3. Hemoglobin A1c (HbA1c) <10% at the Screening Visit.\n- 4. Able to understand, and willingness to sign, the informed consent. For US participants only: must be willing to provide access to personal health information via Health Insurance Portability and Accountability Act (HIPAA) authorization.\n- 5. Willingness and ability to comply with all scheduled visits, restrictions, and assessments.\n- 6. For women of childbearing potential, or men with female partners of childbearing potential, agreement to the use of an appropriate form of contraception at the Screening Visit and for the duration of the study.\n- Ocular Inclusion Criteria for Study Eye: 7. Previously diagnosed with macular edema associated with diabetic retinopathy (DR) at any time For the full list of the inclusion criteria please refer to Protocol section 4.1."}

Exclusion criteria

• {"criterion_text":"- Participants who meet any of the following exclusion criteria will be excluded from the study. 1. Ocular Exclusion Criteria for the Study Eye Only 2. Ocular Exclusion Criteria for Either Eye 3. General Exclusion Criteria For the full list of the exclusion criteria please refer to Protocol section 4.2."}

Primary endpoints

• {"endpoint_text":"- The primary endpoint (or outcome) of this study is to find out whether EYP-1901 can produce the same vision benefits as aflibercept over 56 weeks.","definition_or_measurement_approach":"Efficacy measured as change in best corrected visual acuity (BCVA) over 56 weeks comparing EYP-1901 2686 μg intravitreal (IVT) inserts to aflibercept."}

Secondary endpoints

• {"endpoint_text":"- The secondary endpoints (or outcomes) of the study are to find out: • How often injections are needed over the 56 weeks of treatment\n- • Changes in the thickness of the retina (light-sensitive membrane at the back of the eye) from the first treatment over time\n- • The percentage of participants who maintain, gain, or lose a certain number of letters on an eye chart over time\n- • The percentage of participants who need additional aflibercept injections up to 88 weeks\n- • The total number of additional aflibercept injections needed by Week 88\n- • The percentage of participants whose DME improves over time and also how quickly DME improves over time","definition_or_measurement_approach":"• Injection burden measured as frequency/number of injections over 56 weeks.\n• Retinal thickness measured over time (relative to first treatment) using retinal imaging.\n• Proportion of participants maintaining/gaining/losing specified number of letters on an eye chart (BCVA letters) over time.\n• Proportion of participants requiring additional aflibercept injections up to Week 88.\n• Count of additional aflibercept injections required by Week 88.\n• Proportion and time course of DME improvement over time."}

Methods

• Patient brochure (country-specific versions: CZE, HUN, Treatment_NAIVE, EU) — target audience: patients
• Advocacy/PAG communications (PAG to Patient Email Blast; PAG to Patient FAQ Sheet) — target audience: patient advocacy groups and patients
• Patient email blasts (Advocacy PAG to Patient Email Blast) — digital outreach to patients
• Site awareness posters (Site Awareness Poster; Site Awareness Poster_TREATMENT NAIVE) — target audience: site visitors and patients
• HCP study flyers / HCP Study Flyer (country-specific) — target audience: healthcare professionals (referring clinicians)
• Dr-to-Dr letters (Dr to Dr Letter) — target audience: referring physicians/HCPs
• Clinical trial listing materials (Clinical Trial Listing; PAG Clinical Trial Listing) — target audience: patients and PAGs
• Welcome letter and subject flowchart / study visit guide — for enrolled/prospective participants
• Email communication materials (L2 Other Subject Information_Email_Communication) — digital outreach and follow-up

Germany

Earliest CTIS Part Ii Submission Date

05-03-2026

Latest Decision Or Authorization Date

27-04-2026

Processing Time Days

53

Number Of Sites

1

Number Of Participants

10

Czechia

Earliest CTIS Part Ii Submission Date

06-02-2026

Latest Decision Or Authorization Date

27-04-2026

Processing Time Days

80

Number Of Sites

5

Number Of Participants

40

Hungary

Earliest CTIS Part Ii Submission Date

30-01-2026

Latest Decision Or Authorization Date

02-04-2026

Processing Time Days

62

Number Of Sites

9

Number Of Participants

10

Primary sponsor

Full Name

Eyepoint Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Merit CRO Inc.

Responsibilities

Imaging Center

Name

Syneos Health Netherlands B.V.

Responsibilities

Secondary Vendors Management; multiple central vendor/study management responsibilities (codes provided in sponsor duties)

Name

Almac Clinical Services Limited

Third parties

• {"country":"United States","full_name":"Merit CRO Inc.","duties_or_roles":"Imaging Center","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Optymedge LLC","duties_or_roles":"BCVA VA / Lane Certification","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Netherlands","full_name":"Emsere B.V.","duties_or_roles":"Equipment rental","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Netherlands","full_name":"Syneos Health Netherlands B.V.","duties_or_roles":"Secondary Vendors Management and multiple study vendor management roles (codes listed in sponsor duties)","organisation_type":"Pharmaceutical company"}