Trial record 1 of 1 for:
CRTH-258B-2305
Efficacy and Safety of Brolucizumab vs Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema (DME)
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| ClinicalTrials.gov Identifier: NCT03917472 |
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Recruitment Status :
Recruiting
First Posted : April 17, 2019
Last Update Posted : November 15, 2019
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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 vs. aflibercept in the treatment of patients with visual impairment due to DME.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetic Macular Edema | Drug: Brolucizumab Drug: Aflibercept | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 500 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Masking Description: | A masked evaluating investigator will be responsible for all aspects of the study except the injections and the safety assessment following the injections. An unmasked treating investigator will perform the injections and assess patient safety following the injections. |
| Primary Purpose: | Treatment |
| Official Title: | A 12-Month, 2-Arm, Randomized, Double-Masked, Multicenter Phase III Study Assessing the Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema (KINGFISHER) |
| Actual Study Start Date : | July 17, 2019 |
| Estimated Primary Completion Date : | July 30, 2021 |
| Estimated Study Completion Date : | August 13, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Brolucizumab 6mg q4w
Brolucizumab 6 mg/0.05 mL every 4 weeks.
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Drug: Brolucizumab
Intravitreal injection
Other Name: RTH258, ESBA1008 |
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Active Comparator: Aflibercept 2mg q4w
Aflibercept 2mg/0.05 mL every 4 weeks
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Drug: Aflibercept
Intravitreal injection
Other Name: Eylea |
Primary Outcome Measures :
- Change in best-corrected visual acuity (BCVA) from baseline up to Week 52 [ Time Frame: Week 52 ]Assessed with ETDRS visual acuity testing charts
Secondary Outcome Measures :
- Change from baseline in central subfield thickness (CSFT) at each post-baseline visit [ Time Frame: Baseline up to Week 52 ]Assessed by SD-OCT
- Proportion of study eyes with fluid-free macula at each post-baseline visit [ Time Frame: Baseline up to Week 52 ]Assessed by SD-OCT
- Proportion of study eyes with absence of DME (CSFT < 280 μm) at each post-baseline visit [ Time Frame: Baseline up to Week 52 ]Assessed by SD-OCT
- Time to first fluid-free macula [ Time Frame: Baseline up to Week 52 ]Assessed by SD-OCT
- Time to first absence of DME (CSFT < 280 μm) at each post-baseline visit [ Time Frame: Baseline up to Week 52 ]Assessed by SD-OCT
- Change from baseline in BCVA at each post-baseline visit [ Time Frame: Baseline up to Week 52 ]Assessed with ETDRS visual acuity testing charts
- Proportion of study eyes with gain in BCVA of 5/10/15 letters or more at each post-baseline visit compared to Baseline [ Time Frame: Baseline up to Week 52 ]Assessed with ETDRS visual acuity testing charts
- Change from baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) score [ Time Frame: Baseline uo to Week 52 ]Assessed by color fundus photography
- Percentage of Participants according to Anti-Drug Antibody (ADA) status for brolucizumab [ Time Frame: Baseline up to Week 52 ]Blood draw
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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:
- Signed informed consent must be obtained prior to participation in the study.
- Patients with type 1 or type 2 diabetes mellitus (DM) and Hemoglobin A1c (HbA1c) ≤ 12% at screening.
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Study eye: Visual impairment due to DME with:
- Best-corrected visual acuity (BCVA) score between 73 and 23 letters, inclusive, using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters
- DME involving the center of the macula, with Central Subfield Thickness (CSFT) ≥ 320 µm on Spectral Domain Optical Coherence Tomography (SD-OCT)
Exclusion Criteria:
- High-risk proliferative diabetic retinopathy (PDR) in the study eye
- Concomitant conditions or ocular disorders in the study eye which confound interpretation of study results, compromise visual acuity or require medical or surgical intervention
- Any active intraocular or periocular infection or active intraocular inflammation in the either eye
- Uncontrolled glaucoma in the study eye
- Presence of amblyopia, amaurosis or ocular disorders in the fellow eye with BCVA <20/200
- Use of anti-VEGF therapies, intraocular surgery or laser photocoagulation (macular or panretinal) in the study eye during the 3-month period prior to baseline
- Use of intraocular or periocular corticosteroids in the study eye during the 6-month period prior to baseline, and use of fluocinolone acetonide intravitreal (IVT) implant (Iluvien) at any time prior to baseline
- Prior investigational drugs in either eye, vitreoretinal surgery in the study eye at any time prior to baseline
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): NCT03917472
Contacts
| Contact: Novartis Pharmaceuticals | 1-888-669-6682 | novartis.email@novartis.com | |
| Contact: Novartis Pharmaceuticals | +41613241111 |
Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT03917472 |
| Other Study ID Numbers: |
CRTH258B2305 2019-001004-37 ( EudraCT Number ) |
| First Posted: | April 17, 2019 Key Record Dates |
| Last Update Posted: | November 15, 2019 |
| Last Verified: | November 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| 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 the patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to criteria and process described on www.clinicalstudydatarequest.com |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| 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 Signs and Symptoms Macular Degeneration |
Retinal Degeneration Retinal Diseases Eye Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases |