Clinical Trials List
Protocol NumberKS501P101
Active
2025-03-01 - 2026-12-31
Phase I
Recruiting3
ICD-10H35.81
Retinal edema
ICD-9362.83
Retinal edema
An open-label, multicenter, platform study evaluating the safety, tolerability, bioactivity, and pharmacokinetics of various intravitreal injection therapies in retinal diseases—APEX
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Trial Applicant
ComboTrial Consultancy Ltd .
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Sponsor
ComboTrial Consultancy Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/08/11
Investigators and Locations
Co-Principal Investigator
- 吳政修 Division of Ophthalmology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Yih-Shiou Hwang
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
It is used to treat inflammatory secondary macular edema (MESI) and is being explored as a treatment option for other retinal vascular diseases such as diabetic macular edema (DME).
Objectives
The objective of Part 3 of this trial was to evaluate the ocular and systemic safety, tolerability, and bioactivity of KSI-101 in patients with inflammatory secondary macular edema (MESI).
Test Drug
KSI-101
Active Ingredient
Tabirafusp alfa
Dosage Form
Injectable
Dosage
33 mg/0.33 mL
Endpoints
● From baseline to week 24, study the incidence and severity of ocular and systemic adverse events (AEs) in the study eye.
Inclution Criteria
Ocular Inclusion Criteria:
1. Subjects with inflammatory secondary macular edema (MESI), whether past or concurrent, with a central retinal thickness (CST) ≥ 320 μm on spectral-domain optical coherence tomography (SD-OCT) of the study eye, and leakage confirmed by fundus fluorescein angiography.
2. Diagnosed with acute or chronic active or inactive non-infectious intraocular inflammation.
3. Best-corrected visual acuity (BCVA) of the study eye on the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score is between ≥25 and ≤75 (between Snellen equivalences of 20/32 and ~20/320).
General Inclusion Criteria:
4. Able to sign the Intended Subject Consent Form (ICF), including compliance with the procedures and limitations outlined in the study program.
5. Male or female aged ≥18 years.
6. For Women of Childbearing Age (WOCBP): Agree to abstain from sexual intercourse (avoid heterosexual intercourse) during treatment and for at least 90 days after treatment, or use a contraceptive method with an annual failure rate of <1%. Women of fertility must have a negative urine pregnancy test result on day one of the screening period to be eligible. If the urine pregnancy test is positive, confirmation via a serum pregnancy test is required.
a. Women who have had menarche, have not yet reached postmenopause (absence of menstruation for ≥12 months with no clear cause other than amenorrhea), and have not undergone sterilization (removal of the ovaries and/or uterus) are considered to have fertility potential. The definition of fertility potential may be adjusted based on the local testing hospital or requirements.
b. Examples of contraceptive methods with an annual failure rate of <1% include: bilateral tubal ligation, male sterilization, proven correct use of ovulation-suppressing hormonal contraceptives, hormone-releasing intrauterine devices (IUDs), and copper-containing IUDs.
c. Unacceptable methods of contraception (annual failure rate >1%), such as: cervical caps, diaphragms, or sponges containing spermicide, or male or female condoms with or without spermicide.
d. The reliability of abstinence should be assessed based on the duration of the clinical trial and the participant's preferences and habitual lifestyle. Regular abstinence (e.g., calendar method, ovulation method, symptom-based method, or post-ovulation method) and discontinuation of medication are unacceptable methods of contraception.
7. For men: Consent to abstain from sex or use contraception and consent not to donate sperm, defined as follows:
a. For female partners of fertility potential, men must abstain from sex or use condoms plus other contraceptive methods during treatment and for at least 30 days plus 90 days (sperm production cycle) after the last dose of study drug to ensure an annual failure rate <1%. Men must avoid donating sperm during the same period.
8. Capable and willing to undergo all scheduled visits and assessments.
1. Subjects with inflammatory secondary macular edema (MESI), whether past or concurrent, with a central retinal thickness (CST) ≥ 320 μm on spectral-domain optical coherence tomography (SD-OCT) of the study eye, and leakage confirmed by fundus fluorescein angiography.
2. Diagnosed with acute or chronic active or inactive non-infectious intraocular inflammation.
3. Best-corrected visual acuity (BCVA) of the study eye on the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score is between ≥25 and ≤75 (between Snellen equivalences of 20/32 and ~20/320).
General Inclusion Criteria:
4. Able to sign the Intended Subject Consent Form (ICF), including compliance with the procedures and limitations outlined in the study program.
5. Male or female aged ≥18 years.
6. For Women of Childbearing Age (WOCBP): Agree to abstain from sexual intercourse (avoid heterosexual intercourse) during treatment and for at least 90 days after treatment, or use a contraceptive method with an annual failure rate of <1%. Women of fertility must have a negative urine pregnancy test result on day one of the screening period to be eligible. If the urine pregnancy test is positive, confirmation via a serum pregnancy test is required.
a. Women who have had menarche, have not yet reached postmenopause (absence of menstruation for ≥12 months with no clear cause other than amenorrhea), and have not undergone sterilization (removal of the ovaries and/or uterus) are considered to have fertility potential. The definition of fertility potential may be adjusted based on the local testing hospital or requirements.
b. Examples of contraceptive methods with an annual failure rate of <1% include: bilateral tubal ligation, male sterilization, proven correct use of ovulation-suppressing hormonal contraceptives, hormone-releasing intrauterine devices (IUDs), and copper-containing IUDs.
c. Unacceptable methods of contraception (annual failure rate >1%), such as: cervical caps, diaphragms, or sponges containing spermicide, or male or female condoms with or without spermicide.
d. The reliability of abstinence should be assessed based on the duration of the clinical trial and the participant's preferences and habitual lifestyle. Regular abstinence (e.g., calendar method, ovulation method, symptom-based method, or post-ovulation method) and discontinuation of medication are unacceptable methods of contraception.
7. For men: Consent to abstain from sex or use contraception and consent not to donate sperm, defined as follows:
a. For female partners of fertility potential, men must abstain from sex or use condoms plus other contraceptive methods during treatment and for at least 30 days plus 90 days (sperm production cycle) after the last dose of study drug to ensure an annual failure rate <1%. Men must avoid donating sperm during the same period.
8. Capable and willing to undergo all scheduled visits and assessments.
Exclusion Criteria
Ocular exclusion criteria:
1. Macular edema secondary to diabetes, retinal vein occlusion (RVO), or wet age-related macular degeneration (wAMD) as determined by the trial administrator.
2. Macular structures showing structural changes or disruptions at the fovea or vitreoretinal interface as observed by spectral-domain optical coherence tomography (SD-OCT) of the study eye (including but not limited to subretinal fibrosis, macular atrophy, vitreomacular traction, full-thickness macular hole/lamina defect, or degenerative macular disease).
3. The presence of supraretinal proliferative membrane (ERM) observed by SD-OCT, sufficient to limit the potential of BCVA to improve 15 or more letters, assessed by the image interpretation center and with a final decision made by the trial administrator.
4. Active or suspected ocular infection in either eye during the screening period or on day 1 of the trial, including infectious uveitis.
5. Necrotizing or non-necrotizing scleritis.
6. Current or past history of intraocular/periocular malignancy, including intraocular lymphoma or choroidal melanoma in either eye.
7. History of any intraocular surgery within 4 months after Day 1 of the trial, including cataract surgery in the study eye.
8. Any prior or concurrent administration of periocular or intraocular corticosteroids to the study eye during the following time periods:
a. Use of Dexamethasone/betamethasone or an equivalent subconjunctival steroid within 1 month prior to Day 1 of the trial.
b. Periocular injection of Methylprednisolone (Depo-Medrone) within 2 months prior to Day 1 of the trial.
c. Intravitreal injection of Triamcinolone (Trithesis or Kenalog), or periocular injection, or suprachoroidal injection of Triamcinolone (Xipere) within 2 months prior to Day 1 of the trial.
d. Implantation of Dexamethasone (Ozurdex) within 3 months prior to Day 1 of the trial.
e. Implantation of Fluocinolone acetonide (YUTIQ, ILUVIEN, or Retisert) within the past 3 years prior to Day 1 of the trial.
9. Use of intravitreal anti-vascular endothelial growth factor (VEGF) drugs in the study eye within the past 8 weeks prior to Day 1 of the trial.
10. Previous use of brolucizumab (Beovu) in either eye.
11. Previous use of intravitreal vamikibart in either eye.
12. Use of intravitreal methotrexate within the past month prior to Day 1 of the trial.
13. Aphakia, anterior chamber intraocular lens, or posterior capsule absence, excluding laser capsulotomy after phakic intraocular lens implantation.
14. Laser capsulotomy planned within the past 2 months after Day 1 of the trial or during the trial period.
15. History of vitrectomy, trabeculectomy, or shunt surgery in the study eye prior to Day 1 of the trial.
16. Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥25 mm Hg despite antiglaucoma medication).
17. Non-functional contralateral eye (non-study eye) with best-corrected visual acuity (BCVA) <20 letters.
General exclusion criteria:
18. Systemic oral administration of prednisone or equivalent systemic corticosteroids at a dose greater than 10 mg/day for the four weeks prior to Day 1 of the trial. Patients taking 10 mg or less daily may be included if no dose increase is anticipated during the trial. Dose reduction and discontinuation are permitted during the trial.
19. Currently using systemic immunosuppressive therapy, unless the dose has remained stable for at least four weeks prior to Day 1 of the trial and no dose increase is anticipated during the trial.
20. The following medications should not be used in doses exceeding the recommended levels: methotrexate, 25 mg weekly; mycophenolate mofetil, 3 g daily; cyclosporine, 5 mg/kg daily; azathioprine, 175 mg daily; tacrolimus, 8 mg daily.
21. Systemic cyclophosphamide or chlorambucil is not permitted within one year prior to Day 1 of the trial.
22. Patients who have previously received systemic anti-interleukin-6 (IL-6) therapy but have no record of ocular improvement should not be scheduled for systemic anti-IL-6 therapy within the first 8 weeks of Day 1 of the trial or during the trial period.
1. Macular edema secondary to diabetes, retinal vein occlusion (RVO), or wet age-related macular degeneration (wAMD) as determined by the trial administrator.
2. Macular structures showing structural changes or disruptions at the fovea or vitreoretinal interface as observed by spectral-domain optical coherence tomography (SD-OCT) of the study eye (including but not limited to subretinal fibrosis, macular atrophy, vitreomacular traction, full-thickness macular hole/lamina defect, or degenerative macular disease).
3. The presence of supraretinal proliferative membrane (ERM) observed by SD-OCT, sufficient to limit the potential of BCVA to improve 15 or more letters, assessed by the image interpretation center and with a final decision made by the trial administrator.
4. Active or suspected ocular infection in either eye during the screening period or on day 1 of the trial, including infectious uveitis.
5. Necrotizing or non-necrotizing scleritis.
6. Current or past history of intraocular/periocular malignancy, including intraocular lymphoma or choroidal melanoma in either eye.
7. History of any intraocular surgery within 4 months after Day 1 of the trial, including cataract surgery in the study eye.
8. Any prior or concurrent administration of periocular or intraocular corticosteroids to the study eye during the following time periods:
a. Use of Dexamethasone/betamethasone or an equivalent subconjunctival steroid within 1 month prior to Day 1 of the trial.
b. Periocular injection of Methylprednisolone (Depo-Medrone) within 2 months prior to Day 1 of the trial.
c. Intravitreal injection of Triamcinolone (Trithesis or Kenalog), or periocular injection, or suprachoroidal injection of Triamcinolone (Xipere) within 2 months prior to Day 1 of the trial.
d. Implantation of Dexamethasone (Ozurdex) within 3 months prior to Day 1 of the trial.
e. Implantation of Fluocinolone acetonide (YUTIQ, ILUVIEN, or Retisert) within the past 3 years prior to Day 1 of the trial.
9. Use of intravitreal anti-vascular endothelial growth factor (VEGF) drugs in the study eye within the past 8 weeks prior to Day 1 of the trial.
10. Previous use of brolucizumab (Beovu) in either eye.
11. Previous use of intravitreal vamikibart in either eye.
12. Use of intravitreal methotrexate within the past month prior to Day 1 of the trial.
13. Aphakia, anterior chamber intraocular lens, or posterior capsule absence, excluding laser capsulotomy after phakic intraocular lens implantation.
14. Laser capsulotomy planned within the past 2 months after Day 1 of the trial or during the trial period.
15. History of vitrectomy, trabeculectomy, or shunt surgery in the study eye prior to Day 1 of the trial.
16. Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥25 mm Hg despite antiglaucoma medication).
17. Non-functional contralateral eye (non-study eye) with best-corrected visual acuity (BCVA) <20 letters.
General exclusion criteria:
18. Systemic oral administration of prednisone or equivalent systemic corticosteroids at a dose greater than 10 mg/day for the four weeks prior to Day 1 of the trial. Patients taking 10 mg or less daily may be included if no dose increase is anticipated during the trial. Dose reduction and discontinuation are permitted during the trial.
19. Currently using systemic immunosuppressive therapy, unless the dose has remained stable for at least four weeks prior to Day 1 of the trial and no dose increase is anticipated during the trial.
20. The following medications should not be used in doses exceeding the recommended levels: methotrexate, 25 mg weekly; mycophenolate mofetil, 3 g daily; cyclosporine, 5 mg/kg daily; azathioprine, 175 mg daily; tacrolimus, 8 mg daily.
21. Systemic cyclophosphamide or chlorambucil is not permitted within one year prior to Day 1 of the trial.
22. Patients who have previously received systemic anti-interleukin-6 (IL-6) therapy but have no record of ocular improvement should not be scheduled for systemic anti-IL-6 therapy within the first 8 weeks of Day 1 of the trial or during the trial period.
The Estimated Number of Participants
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Taiwan
13 participants
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Global
54 participants
