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.\tOcular Exclusion Criteria for the Study Eye Only 2.\tOcular Exclusion Criteria for Either Eye 3.\tGeneral 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 assessed over 56 weeks; main objective indicates measurement of changes in best corrected visual acuity (BCVA) comparing EYP-1901 2686 μg 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","definition_or_measurement_approach":"Injection frequency over 56 weeks."}
• {"endpoint_text":"- • Changes in the thickness of the retina (light-sensitive membrane at the back of the eye) from the first treatment over time","definition_or_measurement_approach":"Change in retinal thickness over time from first treatment (e.g., OCT measures)."}
• {"endpoint_text":"- • The percentage of participants who maintain, gain, or lose a certain number of letters on an eye chart over time","definition_or_measurement_approach":"Proportion of participants with specified letter changes on visual acuity charts over time (BCVA letter-change outcomes)."}
• {"endpoint_text":"- • The percentage of participants who need additional aflibercept injections up to 88 weeks","definition_or_measurement_approach":"Proportion of participants requiring supplemental aflibercept injections through Week 88."}
• {"endpoint_text":"- • The total number of additional aflibercept injections needed by Week 88","definition_or_measurement_approach":"Count of supplemental aflibercept injections through Week 88."}
• {"endpoint_text":"- • The percentage of participants whose DME improves over time and also how quickly DME improves over time","definition_or_measurement_approach":"Proportion and time-to-improvement metrics for DME improvement over study follow-up."}

Methods

• Advocacy PAG to Patient Email Blast — channel: email; target audience: patients (documents present for patient email blasts).
• Advocacy PAG to Patient FAQ Sheet — channel: written FAQ distributed via PAG; target audience: patients.
• Dr to Dr letter — channel: physician-to-physician mail/email; target audience: referring HCPs/ophthalmologists.
• HCP Study Flyer — channel: printed/digital flyer for HCPs; target audience: healthcare professionals.
• Patient Brochure and Patient Flowchart — channel: printed/digital patient materials provided at sites; target audience: prospective participants.
• Site Awareness Poster / Site Awareness Poster - Treatment Naive — channel: posters displayed at sites; target audience: clinic visitors/potential participants.
• Patient Welcome Letter and Study Visit Guide — channel: communications provided to participants at site; target audience: enrolled participants.
• GP Letter — channel: letters to general practitioners to raise awareness/referrals.

Poland

Earliest CTIS Part Ii Submission Date

13-03-2026

Latest Decision Or Authorization Date

14-05-2026

Processing Time Days

62

Number Of Sites

6

Number Of Participants

27

Germany

Earliest CTIS Part Ii Submission Date

18-03-2026

Latest Decision Or Authorization Date

14-05-2026

Processing Time Days

57

Number Of Sites

2

Number Of Participants

10

Slovakia

Earliest CTIS Part Ii Submission Date

18-03-2026

Latest Decision Or Authorization Date

14-05-2026

Processing Time Days

57

Number Of Sites

4

Number Of Participants

15

Primary sponsor

Full Name

Eyepoint Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Syneos Health Netherlands B.V.

Responsibilities

Multiple sponsor management responsibilities (codes listed); includes 'Secondary Vendors Management'

Name

Merit CRO Inc.

Responsibilities

Imaging Center

Name

Almac Clinical Services Limited

Responsibilities

Sponsor duties code: 14

Name

Suvoda LLC

Responsibilities

Sponsor duties code: 3

Third parties

• {"country":"United States","full_name":"Optymedge LLC","duties_or_roles":"BCVA VA / Lane Certification","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Netherlands","full_name":"Syneos Health Netherlands B.V.","duties_or_roles":"Sponsor duties codes: 1,10,11,12,13,15 (Secondary Vendors Management),2,5,6,7,8,9","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"Sponsor duties code: 3","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Merit CRO Inc.","duties_or_roles":"Imaging Center","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Sponsor duties code: 7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"Sponsor duties code: 14","organisation_type":"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":"Sponsor duties code: 4","organisation_type":"Pharmaceutical company"}