Trial record 1 of 1 for:
crth258aus04
Study of Safety and Efficacy of Brolucizumab 6 mg Dosed Every 4 Weeks Compared to Aflibercept 2 mg Dosed Every 4 Weeks in Patients With Retinal Fluid Despite Frequent Anti-VEGF Injections (MERLIN)
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| ClinicalTrials.gov Identifier: NCT03710564 |
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Recruitment Status :
Active, not recruiting
First Posted : October 18, 2018
Last Update Posted : February 5, 2020
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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 compare safety and efficacy of brolucizumab 6 mg dosed every 4 weeks to aflibercept 2 mg dosed every 4 weeks in those nAMD patients with retinal fluid despite frequent anti-Vascular Endothelial Growth Factor (VEGF) injections.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Age-Related Macular Degeneration | Biological: Brolucizumab Biological: Aflibercept | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 533 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | multicenter, randomized, double-masked |
| Masking: | Double (Participant, Investigator) |
| Masking Description: | Additionally, the care provider will be masked. |
| Primary Purpose: | Treatment |
| Official Title: | A Multicenter, Randomized, Double-masked Phase 3a Study to Assess Safety and Efficacy of Brolucizumab 6 mg q4 Weeks Compared to Aflibercept 2 mg q4 Weeks in Patients With Neovascular Age-related Macular Degeneration (nAMD) With Persistent Retinal Fluid (MERLIN) |
| Actual Study Start Date : | October 30, 2018 |
| Estimated Primary Completion Date : | June 9, 2020 |
| Estimated Study Completion Date : | January 14, 2022 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Age-related macular degeneration
MedlinePlus related topics:
Macular Degeneration
| Arm | Intervention/treatment |
|---|---|
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Experimental: Masked Arm 1
Brolucizumab 6 mg dosed every 4 weeks from Baseline (Week 0) through Week 100
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Biological: Brolucizumab
6 mg/0.05mL solution for intravitreal injection
Other Name: RTH258 |
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Active Comparator: Masked Arm 2
Aflibercept 2 mg dosed every 4 weeks from Baseline (Week 0) through Week 100
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Biological: Aflibercept
2 mg/0.05mL solution for intravitreal injection
Other Name: EYLEA |
Primary Outcome Measures :
- Change from baseline in Best-Corrected Visual Acuity (BCVA) at Week 52 [ Time Frame: Baseline (Week 0), Week 52 ]BCVA will be assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. Baseline BCVA is defined as the last measurement on or prior to the baseline visit.
Secondary Outcome Measures :
- Stable VA or improvement in VA at Week 52 and Week 104 [ Time Frame: Baseline, Week 52, Week 104 ]BCVA will be assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. The number of subjects with no change or gain in BCVA compared to baseline will be reported.
- Loss in BCVA of 5/10/15 letters or more from baseline to each post-baseline visit [ Time Frame: Baseline, Up to Week 104 ]BCVA will be assessed using the ETDRS visual acuity testing protocol at an initial testing distance of 4 meters. The number of subjects with loss in BCVA of 5/10/15 letters or more from baseline will be reported for each post-baseline visit.
- Gain in BCVA of 5/10/15 letters or more from baseline to each post-baseline visit [ Time Frame: Baseline, Up to Week 104 ]BCVA will be assessed using the ETDRS visual acuity testing protocol at an initial testing distance of 4 meters. The number of subjects with gain in BCVA of 5/10/15 letters or more from baseline will be reported for each post-baseline visit.
- Change in Central Subfield Thickness (CST) from baseline to each post-baseline visit [ Time Frame: Baseline, Up to Week 104 ]CST will be assessed using Spectral Domain Optical Coherence Tomography (SD-OCT) images.
- Intraretinal fluid (IRF) at each post-baseline visit [ Time Frame: Up to Week 104 ]IRF will be assessed using SD-OCT images. The number of subjects with IRF and or SRF (present, absent) will be reported for each post-baseline visit.
- Subretinal fluid (SRF) at each post-baseline visit [ Time Frame: Up to Week 104 ]SRF will be assessed using SD-OCT images. The number of subjects with SRF and or IRF (present, absent) will be reported for each post-baseline visit.
- Sub-Retinal Pigment Epithelium (sub-RPE) fluid in patients with sub-RPE fluid at baseline [ Time Frame: Baseline, Up to Week 104 ]Sub-RPE fluid will be assessed using SD-OCT images. The number of subjects with sub-RPE fluid in subjects with sub-RPE fluid at baseline (present, absent) will be reported for each post-baseline visit.
- Fluid-free status (no IRF, SRF or sub-RPE fluid) at each post-baseline treatment visit [ Time Frame: Up to Week 104 ]IRF, SRF, and sub-RPE fluid will assessed using SD-OCT images. The number of subjects with fluid-free status (no IRF, SRF, or sub-RPE) will be reported for each post-baseline visit.
- Time to first dry retina (no IRF or SRF) finding [ Time Frame: Time to event (Baseline, Up to Week 104) ]IRF and SRF will be assessed using SD-OCT images. A dry retina is defined as no IRF or SRF at the visit.
- Time to first sustained dry retina (no IRF or SRF at ≥ 2 consecutive visits) finding [ Time Frame: Time to event (Baseline, Up to Week 104) ]IRF and SRF will be assessed using SD-OCT images. A sustained dry retina is defined as no IRF or SRF at 2 or more consecutive visits.
- Change in anti-drug antibody (ADA) levels from baseline [ Time Frame: Baseline, Up to Week 104 ]A blood sample will be collected. The baseline sample will be collected prior to first dose of study treatment. This outcome measure is pre-specified for the brolucizumab arm only.
- Change in systemic brolucizumab levels from baseline [ Time Frame: Baseline, Up to Week 104 ]A blood sample will be collected. The baseline sample will be collected prior to first dose of study treatment. This outcome measure is pre-specified for the brolucizumab arm only.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Sign informed consent
- Diagnosis of wet age-related macular degeneration (AMD)
- Currently receiving anti-VEGF injections
Exclusion Criteria:
- Active infection or inflammation in either eye
- Significant fibrosis in the study eye
- Recent ocular surgery
- Uncontrolled glaucoma
- Use of medications as specified in the protocol
- Pregnant, nursing
- Of child-bearing potential unless using highly effective method of contraception
Other protocol-defined 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): NCT03710564
Locations
Show 63 study locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT03710564 |
| Other Study ID Numbers: |
CRTH258AUS04 |
| First Posted: | October 18, 2018 Key Record Dates |
| Last Update Posted: | February 5, 2020 |
| Last Verified: | February 2020 |
| 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 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 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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neovascular age-related macular degeneration nAMD intravitreal injection IVT anti-VEGF brolucizumab |
aflibercept EYLEA double-masked MERLIN BEOVU |
Additional relevant MeSH terms:
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Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Bevacizumab Antineoplastic Agents, Immunological |
Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |