Clinical Trials List
Protocol NumberCRTH258B2302
2018-07-31 - 2021-05-04
Phase III
Terminated3
ICD-10E08.311
Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy with macular edema
ICD-9250.50
Diabetes with ophthalmic manifestations, Type II [non-insulin dependent type][NIDDM type][adult-onset type ] or unspecified type ,not stated as uncontrolled
A Two-Year, Two-Arm, Randomized, Double-Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab versus Aflibercept in Adult Patients with Visual Impairment due to Diabetic Macular Edema (KITE)
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Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 劉珍吟 無
- Wei-Chi WU Division of Ophthalmology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- 陳文祿 Division of Ophthalmology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Diabetic Macular Edema (KITE)
Objectives
Primary Objective(s)
To demonstrate that brolucizumab is noninferior to aflibercept with respect to the visual outcome after the first year of treatment
Secondary Objective(s)
To demonstrate that brolucizumab is noninferior to aflibercept with respect to visual
outcome during the last 3 months of the first year of treatment
To estimate the proportion of patients treated at q12w frequency with brolucizumab
To estimate the predictive value of the first q12w cycle for maintenance of q12w treatment with brolucizumab
Test Drug
RTH258
Active Ingredient
RTH258 (Brolucizumab)
Dosage Form
solution for injection
Dosage
6mg
Endpoints
Change from baseline in BCVA at Week 52
Change from baseline in BCVA averaged over a period Week 40 to Week 52
Proportion of patients maintained at q12w up to Weeks 52 & 100
Proportion of patients maintained at q12w up to Week 52, within those patients that qualified for
q12w at Week 36
Proportion of patients maintained at q12w/q16w up to Week 100, within those patients that qualified for q12w at Week 36
Proportion of patients maintained on q16w up to Week 100 within the patients on q12w at Week 68
and on q16w at Week 76
Proportion of patients re-assigned and maintained on q12w up to Week 100 within the patients on q8w at Week 68 and on q12w at Week 80
Change from baseline in BCVA averaged over a period Week 40 to Week 52
Proportion of patients maintained at q12w up to Weeks 52 & 100
Proportion of patients maintained at q12w up to Week 52, within those patients that qualified for
q12w at Week 36
Proportion of patients maintained at q12w/q16w up to Week 100, within those patients that qualified for q12w at Week 36
Proportion of patients maintained on q16w up to Week 100 within the patients on q12w at Week 68
and on q16w at Week 76
Proportion of patients re-assigned and maintained on q12w up to Week 100 within the patients on q8w at Week 68 and on q12w at Week 80
Inclution Criteria
Inclusion criteria
Patients eligible for inclusion in this study must fulfill all of the following criteria:
1. Written informed consent must be obtained before any assessment is performed.
2. Patients ≥18 years of age at baseline
3. Patients with type 1 or type 2 diabetes mellitus and HbA1c of ≤10% at screening.
4. Medication for the management of diabetes must have been stable within 3 months prior
to randomization and is expected to remain stable during the course of the study
Study Eye
5. Visual impairment due to DME with:
• BCVA score between 78 and 23 letters, inclusive, using ETDRS visual acuity testing
charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/32
to 20/320) at screening and baseline
• DME involving the center of the macula, with central subfield retinal thickness
(measured from RPE to ILM inclusively) of ≥320 µm on SD-OCT at screening
If both eyes are eligible, the eye with the worse visual acuity will be selected for study eye.
However, the investigator may select the eye with better visual acuity, based on medical reasons
or local ethical requirements.
Patients eligible for inclusion in this study must fulfill all of the following criteria:
1. Written informed consent must be obtained before any assessment is performed.
2. Patients ≥18 years of age at baseline
3. Patients with type 1 or type 2 diabetes mellitus and HbA1c of ≤10% at screening.
4. Medication for the management of diabetes must have been stable within 3 months prior
to randomization and is expected to remain stable during the course of the study
Study Eye
5. Visual impairment due to DME with:
• BCVA score between 78 and 23 letters, inclusive, using ETDRS visual acuity testing
charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/32
to 20/320) at screening and baseline
• DME involving the center of the macula, with central subfield retinal thickness
(measured from RPE to ILM inclusively) of ≥320 µm on SD-OCT at screening
If both eyes are eligible, the eye with the worse visual acuity will be selected for study eye.
However, the investigator may select the eye with better visual acuity, based on medical reasons
or local ethical requirements.
Exclusion Criteria
Exclusion criteria
Patients fulfilling any of the following criteria are not eligible for inclusion in this study. No
additional exclusions may be applied by the investigator, in order to ensure that the study
population will be representative of all eligible patients:
1. Active Proliferative diabetic retinopathy in the study eye as per investigator
2. Concomitant conditions or ocular disorders in the study eye at screening or baseline
which could, in the opinion of the investigator, prevent response to study treatment or
may confound interpretation of study results, compromise visual acuity or require
medical or surgical intervention during the first 12-month study period (e.g., cataract,
vitreous hemorrhage, retinal vascular occlusion, retinal detachment, macular hole, or
choroidal neovascularization of any cause)
3. Any active intraocular or periocular infection or active intraocular inflammation
(e.g., infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis,
uveitis) in study eye at screening or baseline
4. Structural damage of the fovea in the study eye at screening likely to preclude
improvement in visual acuity following the resolution of macular edema, including
atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), epiretinal
membrane involving fovea or organized hard exudate plaques
5. Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25
mmHg on medication or according to investigator’s judgment at Screening or Baseline
6. Neovascularization of the iris in the study eye at screening or baseline
7. Evidence of vitreomacular traction in the study eye at screening or baseline which in the
opinion of the investigator, affects visual acuity
8. Presence of amblyopia, amaurosis or ocular disorders with vision <20/200 (35 letters)
in the fellow eye at screening or baseline
9. History of idiopathic or autoimmune uveitis in the study eye
Patients fulfilling any of the following criteria are not eligible for inclusion in this study. No
additional exclusions may be applied by the investigator, in order to ensure that the study
population will be representative of all eligible patients:
1. Active Proliferative diabetic retinopathy in the study eye as per investigator
2. Concomitant conditions or ocular disorders in the study eye at screening or baseline
which could, in the opinion of the investigator, prevent response to study treatment or
may confound interpretation of study results, compromise visual acuity or require
medical or surgical intervention during the first 12-month study period (e.g., cataract,
vitreous hemorrhage, retinal vascular occlusion, retinal detachment, macular hole, or
choroidal neovascularization of any cause)
3. Any active intraocular or periocular infection or active intraocular inflammation
(e.g., infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis,
uveitis) in study eye at screening or baseline
4. Structural damage of the fovea in the study eye at screening likely to preclude
improvement in visual acuity following the resolution of macular edema, including
atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), epiretinal
membrane involving fovea or organized hard exudate plaques
5. Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25
mmHg on medication or according to investigator’s judgment at Screening or Baseline
6. Neovascularization of the iris in the study eye at screening or baseline
7. Evidence of vitreomacular traction in the study eye at screening or baseline which in the
opinion of the investigator, affects visual acuity
8. Presence of amblyopia, amaurosis or ocular disorders with vision <20/200 (35 letters)
in the fellow eye at screening or baseline
9. History of idiopathic or autoimmune uveitis in the study eye
The Estimated Number of Participants
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Taiwan
25 participants
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Global
356 participants
