A Study of the Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema (KITE)
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| ClinicalTrials.gov Identifier: NCT03481660 |
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Recruitment Status :
Active, not recruiting
First Posted : March 29, 2018
Last Update Posted : February 26, 2021
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of brolucizumab in treatment of patients with visual impairment due to diabetic macular edema (DME).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetic Macular Edema | Drug: Brolucizumab Drug: Aflibercept | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 361 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Actual Study Start Date : | July 27, 2018 |
| Actual Primary Completion Date : | June 29, 2020 |
| Estimated Study Completion Date : | July 16, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Brolucizumab 6 mg
Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
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Drug: Brolucizumab
Intravitreal injection
Other Name: RTH258, ESBA1008 |
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Active Comparator: Aflibercept 2 mg
Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks
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Drug: Aflibercept
Intravitreal injection
Other Name: Eylea |
Primary Outcome Measures :
- Change from baseline in best-corrected visual acuity (BCVA) at Week 52 [ Time Frame: Baseline, Week 52 ]BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts
Secondary Outcome Measures :
- Average change from baseline in BCVA over the period Week 40 through Week 52 [ Time Frame: Baseline up to Week 52 ]Assessed with ETDRS visual acuity testing charts
- Proportion of patients maintained at q12w up to Weeks 52 and 100 [ Time Frame: Up to Week 100 ]Positive treatment status is defined as IVT injections per planned dosing regimen [every 12 weeks (q12w)]. This outcome measure is pre-specified for brolucizumab treatment arm only.
- Proportion of patients maintained at q12w up to Week 52 within those patients that qualified for q12w at Week 36 [ Time Frame: Up to Week 52 ]This outcome measure is pre-specified for brolucizumab treatment arm only.
- Change from baseline in BCVA at each visit up to Week 100 [ Time Frame: Baseline up to Week 100 ]Assessed with ETDRS visual acuity testing charts
- Average change from baseline in BCVA over the period Week 4 to Week 52/100 [ Time Frame: Baseline up to Week 100 ]Assessed with ETDRS visual acuity testing charts
- Average change from baseline in BCVA over the period Week 20 to Week 52/100 and Week 28 to Week 52/100 [ Time Frame: Baseline up to Week 100 ]Assessed with ETDRS visual acuity testing charts
- Gain in BCVA of ≥5, ≥10, and ≥15 ETDRS letters from baseline to each post-baseline visit [ Time Frame: Baseline up to Week 100 ]Assessed with ETDRS visual acuity testing charts
- Time to achieve gain in BCVA of ≥5, ≥10, and ≥15 ETDRS letters from baseline (or reaching a score of 84 or more) [ Time Frame: Baseline up to Week 100 ]Assessed with ETDRS visual acuity testing charts
- Loss in BCVA of ≥5, ≥10, and ≥15 ETDRS letters from baseline to each post-baseline visit [ Time Frame: Baseline up to Week 100 ]Assessed with ETDRS visual acuity testing charts
- Absolute BCVA ≥73 ETDRS letters at each post-baseline visit [ Time Frame: Baseline up to Week 100 ]Assessed with ETDRS visual acuity testing charts
- Proportion of patients maintained at q12w up to Week 64 (after three q12w- treatment intervals) [ Time Frame: Up to Week 64 ]
- Proportion of patients maintained at q12w up to Week 64 (after three q12w- treatment intervals), within those patients that qualified for q12w at Week 36 [ Time Frame: Up to Week 64 ]This outcome measure is pre-specified for brolucizumab treatment arm only
- Proportion of patients maintained at q12w/q16w up to Week 100, within those patients that qualified for q12w at Week 36 [ Time Frame: Up to Week 100 ]This outcome measure is pre-specified for brolucizumab treatment arm only
- Proportion of patients with disease activity at Week 32 (eg ≥5 letters loss in BCVA compared to Week 28) [ Time Frame: Week 28, Week 32 ]This outcome measure is pre-specified for brolucizumab treatment arm only
- Proportion of patients maintained on q16w up to Week 100 within the patients on q12 at Week 68 and on q16w at Week 76 [ Time Frame: Up to Week 100 ]
- 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 [ Time Frame: Up to Week 100 ]
- Proportion of patients with injections per planned dosing regimen (every 8, 12 or 16 weeks) [ Time Frame: Up to Week 100 ]This outcome measure is pre-specified for brolucizumab treatment arm only
- Change from baseline in central subfield thickness (CSFT) at each assessment visit [ Time Frame: Baseline up to Week 100 ]Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT)
- Average change from baseline in CSFT over the period Week 40 through Week 52 / Week 88 through Week 100 [ Time Frame: Baseline up to Week 100 ]Assessed by SD-OCT
- Average change from baseline in CSFT over the period Week 4 to Week 52 / 96 [ Time Frame: Baseline up to Week 96 ]Assessed by SD-OCT
- Patient status regarding normal CSFT thickness (<280 microns) at each assessment visit [ Time Frame: Baseline up to Week 100 ]Assessed by SD-OCT
- Change from baseline in central subfield thickness-neurosensory (CSFTns) at each assessment visit [ Time Frame: Baseline up to Week 100 ]Assessed by SD-OCT
- Average change from baseline in CSFTns over the period Week 40 through Week 52 / Week 88 through Week 100 [ Time Frame: Baseline up to Week 100 ]Assessed by SD-OCT
- Average change from baseline in CSFTns over the period Week 4 to Week 52 / 100 [ Time Frame: Baseline up to Week 100 ]
- Proportion of patients with presence of subretinal fluid (SRF) at each assessment visit [ Time Frame: Baseline up to Week 100 ]Assessed by SD-OCT, angiography, and/or color fundus photography
- Proportion of patients with presence of intraretinal fluid (IRF) at each assessment visit [ Time Frame: Baseline up to Week 100 ]Assessed by SD-OCT, angiography, and/or color fundus photography
- Proportion of patients with simultaneous absence of SRF and IRF at each assessment visit [ Time Frame: Baseline up to Week 100 ]Assessed by SD-OCT, angiography, and/or color fundus photography
- Proportion of patients with presence of leakage on fluorescein angiography (FA) at Weeks 52 and 100 [ Time Frame: Up to Week 100 ]Assessed by fluorescein angiography
- Change from baseline in ETDRS Diabetic Retinopathy Severity Scale (ETDRS-DRSS) score at each assessment visit [ Time Frame: Baseline up to Week 100 ]The Diabetic Retinopathy Disease Severity Scale measures the 5 levels of diabetic retinopathy - none, mild, moderate, severe, and proliferative
- Number of patients with progression to proliferative diabetic retinopathy (PDR) as assessed by ETDRS-DRSS Score of at least 61 by Week 52 and Week 100 [ Time Frame: Baseline up to Week 100 ]ETDRS-DRSS
- Change from baseline in patient reported outcomes (VFQ-25) total and subscale scores up to Week 100 [ Time Frame: Baseline up to Week 100 ]The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains
- Systemic brolucizumab/aflibercept concentration [ Time Frame: Up to Week 24 ]Blood draw
- Anti-Drug Antibody (ADA) status [ Time Frame: Up to Week 100 ]Blood draw
- Average change from baseline in BCVA from the period Week 88 to 100 [ Time Frame: Baseline up to Week 100 ]Assessed with ETDRS visual acuity testing charts
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Written informed consent before any assessment
- Patients with type 1 or type 2 diabetes mellitus and HbA1c of ≤10% at screening
- Medication for the management of diabetes stable within 3 months prior to randomization and is expected to remain stable during the course of the study
Exclusion Criteria:
- Active proliferative diabetic retinopathy in the study eye
- Active intraocular or periocular infection or active intraocular inflammation in the study eye
- Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25 millimeters mercury (mmHg)
- Previous treatment with anti-VEGF drugs or investigational drugs in the study eye
- Stroke or myocardial infarction during the 6-month period prior to baseline
- Uncontrolled blood pressure defined as a systolic value ≥160 mmHg or diastolic value ≥100 mmHg
Other protocol-specified inclusion/exclusion criteria may apply
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03481660
Locations
Show 78 study locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT03481660 |
| Other Study ID Numbers: |
CRTH258B2302 2017-003960-11 ( EudraCT Number ) |
| First Posted: | March 29, 2018 Key Record Dates |
| Last Update Posted: | February 26, 2021 |
| Last Verified: | February 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Plan Description: | Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on ww.clinicalstudydatarequest.com. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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Diabetic Macular Edema intravitreal injection brolucizumab aflibercept double-masked |
Additional relevant MeSH terms:
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Vision Disorders Vision, Low Macular Edema Edema Macular Degeneration Retinal Degeneration |
Retinal Diseases Eye Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases |