Neovascular (Wet) Age-Related Macular DegenerationPhase 2CANDELANCT04126317
Safety, Tolerability, and Efficacy of Aflibercept in Patients With Neovascular Age-Related Macular Degeneration
A Phase 2 study testing aflibercept and High-dose aflibercept in people with Neovascular (Wet) Age-Related Macular Degeneration, run by Regeneron Pharmaceuticals at 46 sites in 2 countries.
Trial summary
The primary objectives of the study are to determine the safety of high-dose aflibercept (hereafter referred to as HD) and to determine if HD provides greater intraocular pharmacodynamic (PD) effect and/or longer duration of action compared to intravitreal aflibercept injection (hereafter referred to as IAI). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular (Wet) Age-Related Macular Degeneration
- What is being tested?
- aflibercept and High-dose aflibercept
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 46 sitesin 2 countries
- Study dates
- 4 Nov 2019to 30 Nov 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women ≥50 years of age with active subfoveal choroidal neovascularization (CNV) secondary to nAMD
- Best Corrected Visual Acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 78 to 24 (Snellen equivalent of 20/32 to 20/320) in the study eye
Who cannot join
- Evidence of CNV due to any cause other than nAMD in either eye
- Evidence of diabetic macular edema (DME) or diabetic retinopathy (defined as more than 1 microaneurysm) in either eye in diabetic patients
- Prior use of IVT anti-VEGF agents (aflibercept, ranibizumab, bevacizumab, brolucizumab, pegaptanib sodium) in the study eye
- Prior IVT investigational agents in either eye (eg, anti-ang-2/anti-VEGF bispecific monoclonal antibodies, gene therapy)
- Previous use of intraocular or periocular corticosteroids within 120 days of screening or treatment with an IVT steroid implant at any time in the study eye
- History of vitreoretinal surgery (including scleral buckling) in the study eye
Show all 9Show fewer
- Any other intraocular surgery within 12 weeks (84 days) before the screening visit
- History of corneal transplant or corneal dystrophy in study eye
- NOTE: Other protocol defined inclusion/exclusion criteria apply.
Trial locations and contacts
46 sites in 2 countries.
46 sites in 2 countries
United States45 sites
Regeneron Study Site
Abilene, Texas, 79606
Regeneron Study Site
Albuquerque, New Mexico, 87102
Regeneron Study Site
Arlington, Texas, 76012
Regeneron Study Site
Asheville, North Carolina, 28803
Regeneron Study Site
Augusta, Georgia, 30909
Regeneron Study Site
Austin, Texas, 78705
Regeneron Study Site
Bloomfield, New Jersey, 07003
Regeneron Study Site
Charlotte, North Carolina, 28210
Regeneron Study Site
Colorado Springs, Colorado, 80909
Regeneron Study Site
Columbus, Ohio, 43212
Regeneron Study Site
Edmond, Oklahoma, 73013
Regeneron Study Site
Encino, California, 91436
Regeneron Study Site
Fairfax, Virginia, 22031
Regeneron Study Site
Fort Lauderdale, Florida, 33309
Regeneron Study Site
Fort Myers, Florida, 33912
Regeneron Study Site
Fullerton, California, 92835
Regeneron Study Site
Golden, Colorado, 80401
Regeneron Study Site
Great Neck, New York, 11021
Regeneron Study Site
Hagerstown, Maryland, 21740
Regeneron Study Site
Houston, Texas, 77030
Regeneron Study Site
Kingston, Pennsylvania, 18704
Regeneron Study Site
Ladson, South Carolina, 29456
Regeneron Study Site
Lakeland, Florida, 33805
Regeneron Study Site
Largo, Florida, 33770
Regeneron Study Site
Marietta, Georgia, 30060
Regeneron Study Site
Melbourne, Florida, 32901
Regeneron Study Site
Morgantown, West Virginia, 26506
Regeneron Study Site
Mountain View, California, 94040
Regeneron Study Site
Oak Forest, Illinois, 60452
Regeneron Study Site
Palm Desert, California, 92211
Regeneron Study Site
Phoenix, Arizona, 85020
Regeneron Study Site
Portland, Oregon, 97221
Regeneron Study Site
Rapid City, South Dakota, 57701
Regeneron Study Site
Royal Oak, Michigan, 48073
Regeneron Study Site
Sacramento, California, 95819
Regeneron Study Site
Salt Lake City, Utah, 84107
Regeneron Study Site
Santa Ana, California, 92705
Regeneron Study Site
Spokane, Washington, 99204
Regeneron Study Site
Sun City, Arizona, 85351
Regeneron Study Site
Tallahassee, Florida, 32308
Regeneron Study Site
Teaneck, New Jersey, 07666
Regeneron Study Site
The Woodlands, Texas, 77384
Regeneron Study Site
Waterford, Connecticut, 06385
Regeneron Study Site
West Columbia, South Carolina, 29169
Regeneron Study Site
Winter Haven, Florida, 33880
About this study
Official title: A Randomized, Single-Masked, Active-Controlled Phase 2 Study of the Safety, Tolerability, and Efficacy of Repeated Doses of High-Dose Aflibercept in Patients With Neovascular Age-Related Macular Degeneration
The primary objectives of the study are to determine the safety of high-dose aflibercept (hereafter referred to as HD) and to determine if HD provides greater intraocular pharmacodynamic (PD) effect and/or longer duration of action compared to intravitreal aflibercept injection (hereafter referred to as IAI).
- Being tested
- aflibercept, High-dose aflibercept
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
afliberceptDrug
Also called EYLEA®, BAY86-5321
Intravitreally (IVT) administered as a liquid formulation in a vial
High-dose afliberceptDrug
Intravitreally (IVT) administered as a liquid formulation in a vial
| Study group | Role | What they receive |
|---|---|---|
| intravitreal aflibercept injection (IAI) | Experimental | Treatment-naïve patients with neovascular "wet" age-related macular degeneration (nAMD) randomized in a 1:1 ratio Receives: Drug: aflibercept |
| High-dose aflibercept (HD) | Experimental | Treatment-naïve patients with nAMD randomized in a 1:1 ratio Receives: Drug: High-dose aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
Measured: Up to Week 44
Number of Participants With at Least One Serious TEAE
Measured: Up to Week 44
Number of Participants Without Retinal Fluid in the Center Subfield of Study Eye
Center subfield=the circular area in 1 millimeter (mm) diameter centered around the center point of the fovea. Without fluid defined as absence of intraretinal fluid (IRF) and/or subretinal fluid (SRF) in the center subfield. Presence of retinal fluid was assessed by spectral domain optical coherence tomography (SD-OCT)
Measured: At Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start4 Nov 2019
- Primary completion14 May 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neovascular (Wet) Age-Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04126317
- Sponsor's protocol ID
- VGFTe (HD)-AMD-1905
- Acronym
- CANDELA
- Status last verified
- Jul 2023
- First submitted
- 11 Oct 2019
- Last updated
- 14 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Publications
Wykoff CC, Brown DM, Reed K, Berliner AJ, Gerstenblith AT, Breazna A, Abraham P, Fein JG, Chu KW, Clark WL, Leal S, Schmelter T, Hirshberg B, Yancopoulos GD, Vitti R; CANDELA Study Investigators. Effect of High-Dose Intravitreal Aflibercept, 8 mg, in Patients With Neovascular Age-Related Macular Degeneration: The Phase 2 CANDELA Randomized Clinical Trial. JAMA Ophthalmol. 2023 Sep 1;141(9):834-842. doi: 10.1001/jamaophthalmol.2023.2421.
PubMed 37535382
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Masked, Active-Controlled Phase 2 Study of the Safety, Tolerability, and Efficacy of Repeated Doses of High-Dose Aflibercept in Patients With Neovascular Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT04126317
- Acronym / sponsor ID
- CANDELA / VGFTe (HD)-AMD-1905
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Bayer
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 14 May 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 15 Oct 2019 (actual)
- Results
- Posted 14 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of the study are to determine the safety of high-dose aflibercept (hereafter referred to as HD) and to determine if HD provides greater intraocular pharmacodynamic (PD) effect and/or longer duration of action compared to intravitreal aflibercept injection (hereafter referred to as IAI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intravitreal aflibercept injection (IAI) | Experimental | Drug: afliberceptTreatment-naïve patients with neovascular "wet" age-related macular degeneration (nAMD) randomized in a 1:1 ratio |
| High-dose aflibercept (HD) | Experimental | Drug: High-dose afliberceptTreatment-naïve patients with nAMD randomized in a 1:1 ratio |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men or women ≥50 years of age with active subfoveal choroidal neovascularization (CNV) secondary to nAMD
- Best Corrected Visual Acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 78 to 24 (Snellen equivalent of 20/32 to 20/320) in the study eye
Key exclusion criteria (9 listed)
- Evidence of CNV due to any cause other than nAMD in either eye
- Evidence of diabetic macular edema (DME) or diabetic retinopathy (defined as more than 1 microaneurysm) in either eye in diabetic patients
- Prior use of IVT anti-VEGF agents (aflibercept, ranibizumab, bevacizumab, brolucizumab, pegaptanib sodium) in the study eye
- Prior IVT investigational agents in either eye (eg, anti-ang-2/anti-VEGF bispecific monoclonal antibodies, gene therapy)
- Previous use of intraocular or periocular corticosteroids within 120 days of screening or treatment with an IVT steroid implant at any time in the study eye
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| afliberceptAlso: EYLEA®, BAY86-5321Intravitreally (IVT) administered as a liquid formulation in a vial | Drug | intravitreal aflibercept injection (IAI) |
| High-dose afliberceptIntravitreally (IVT) administered as a liquid formulation in a vial | Drug | High-dose aflibercept (HD) |
Primary outcome
Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
Time frame: Up to Week 44
Number of Participants With at Least One Serious TEAE
Time frame: Up to Week 44
Number of Participants Without Retinal Fluid in the Center Subfield of Study Eye
Time frame: At Week 16
Center subfield=the circular area in 1 millimeter (mm) diameter centered around the center point of the fovea. Without fluid defined as absence of intraretinal fluid (IRF) and/or subretinal fluid (SRF) in the center subfield. Presence of retinal fluid was assessed by spectral domain optical coherence tomography (SD-OCT)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37535382Wykoff CC, Brown DM, Reed K, Berliner AJ, Gerstenblith AT, Breazna A, Abraham P, Fein JG, Chu KW, Clark WL, Leal S, Schmelter T, Hirshberg B, Yancopoulos GD, Vitti R; CANDELA Study Investigators. Effect of High-Dose Intravitreal Aflibercept, 8 mg, in Patients With Neovascular Age-Related Macular Degeneration: The Phase 2 CANDELA Randomized Clinical Trial. JAMA Ophthalmol. 2023 Sep 1;141(9):834-842. doi: 10.1001/jamaophthalmol.2023.2421.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
46 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing aflibercept and High-dose aflibercept in people with Neovascular (Wet) Age-Related Macular Degeneration, run by Regeneron Pharmaceuticals at 46 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) (time frame: Up to Week 44). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04126317, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.