A Prospective, Multicenter, Open-Label, Observational Phase 4 Study to Evaluate Real-World Safety, Tolerability, and Treatment Patterns of Pegcetacoplan (Syfovre) in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
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| ClinicalTrials.gov Identifier: NCT06161584 |
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Recruitment Status :
Recruiting
First Posted : December 8, 2023
Last Update Posted : February 21, 2024
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Sponsor:
Apellis Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Apellis Pharmaceuticals, Inc.
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Brief Summary:
A Prospective, Multicenter, Open-Label, Observational Phase 4 Study to Evaluate Real-World Safety, Tolerability, and Treatment Patterns of Pegcetacoplan (Syfovre) in Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration
| Condition or disease | Intervention/treatment |
|---|---|
| Geographic Atrophy | Drug: Pegcetacoplan |
| Study Type : | Observational |
| Estimated Enrollment : | 300 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | A Prospective, Multicenter, Open-Label, Observational Phase 4 Study to Evaluate Real-World Safety, Tolerability, and Treatment Patterns of Pegcetacoplan (Syfovre) in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration |
| Actual Study Start Date : | September 28, 2023 |
| Estimated Primary Completion Date : | October 2027 |
| Estimated Study Completion Date : | October 2027 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Age-related macular degeneration
MedlinePlus related topics:
Macular Degeneration
Drug Information
available for:
Pegcetacoplan
| Group/Cohort | Intervention/treatment |
|---|---|
| Observation |
Drug: Pegcetacoplan
Administered intravitreally (IVT) in eyes with geographic atrophy (GA)
Other Name: Syfovre |
Primary Outcome Measures :
- Incidence of ocular AEs in treated eyes overall and according to physician-directed treatment interval based on US prescribing information [ Time Frame: Up to 36 months ]
- Incidence of other events of interest [ Time Frame: Up to 36 months ]
Secondary Outcome Measures :
- Assess real-world treatment patterns and use of pegcetacoplan considering the proportion of participants with bilateral GA treated with pegcetacoplan in both eyes [ Time Frame: Up to 36 months ]
- If only one eye is treated, the criteria for determination of the eye to be treated [ Time Frame: Up to 36 months ]
- The treatment interval (mean days between injections) over time [ Time Frame: Up to 36 months ]
- The frequency of imaging on treated eyes (color fundus photography, spectral domain optical coherence tomography [SD-OCT], fundus autofluorescence, optical coherence tomography angiography [OCT-A [ Time Frame: Up to 36 months ]
- The treatment adherence to planned dosing frequency: the number of injections administered divided by the number of injections planned [ Time Frame: Up to 36 months ]
- The duration of persistence on treatment: continuous medication usage until a gap of ≥3 months [ Time Frame: Up to 36 months ]
- The treatment discontinuation and/or switching to other agents approved for treatment of GA [ Time Frame: Up to 36 months ]
- The management of new-onset exudative age-related macular degeneration (eAMD) events in eyes treated with pegcetacoplan in clinical practice [ Time Frame: Up to 36 months ]
- The proportion of treated eyes that develop eAMD that receive anti-vascular endothelial growth factor (VEGF) injections [ Time Frame: Up to 36 months ]
- The number of anti-VEGF injections per month from diagnosis of eAMD [ Time Frame: Up to 36 months ]
- The proportion of anti-VEGF injections given on same day in the same eye as pegcetacoplan [ Time Frame: Up to 36 months ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients residing in the United States who are 60 years or older who have geographic atrophy secondary to age-related macular degeneration
Criteria
Inclusion Criteria: Eyes are eligible to be included in the study only if all of the following criteria apply. Ocular-specific inclusion criteria apply to the treated eye(s), unless otherwise specified.
- Eyes that are naive to treatment with pegcetacoplan that are prescribed pegcetacoplan per routine clinical practice according to approved pegcetacoplan prescribing information (ie, the clinical decision to treat with pegcetacoplan must be made before study participation is discussed with the patient)
- Patient age ≥60 years
- Visual acuity better than 20/200 on Snellen chart
- Clinical diagnosis of GA of the macula secondary to AMD in one or both eyes as determined by the investigator using OCT and/or FAF imaging
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GA lesion meeting the following criteria as determined by the investigator's assessment of Spectralis OCT and/or FAF images at screening:
- Nonsubfoveal lesion(s)
- GA lesion visualized in its entirety on the macula-centered OCT image and not contiguous with any areas of peripapillary atrophy
- Presence of any pattern of hyperautofluorescence in the junctional zone of GA; absence of hyperautofluorescence (ie, pattern = none) exclusionary
- Adequate clarity of ocular media and adequate pupillary dilation and fixation to permit the collection of good quality images as determined by the investigator
- Patient willing and able to give informed consent and to comply with the study procedures and assessments
Exclusion Criteria: Ocular-specific exclusion criteria apply to the study eye(s) only, unless otherwise specified.
- GA secondary to a condition other than AMD such as Stargardt disease, cone rod dystrophy, or toxic maculopathies like Plaquenil maculopathy in either eye
- Active, suspected, or history of intraocular inflammation in either eye at screening or on day 1
- Any history of or active choroidal neovascularization associated with AMD or any other cause, including any evidence of retinal pigment epithelial tears or rips in SD OCT imaging
- Presence of an active ocular disease that in the opinion of the investigator compromises or confounds visual function, including but not limited to uveitis and other macular diseases (eg, clinically significant epiretinal membrane, full thickness macular hole, uncontrolled glaucoma/ocular hypertension). Conditions that in the opinion of the investigator are benign, such as peripheral retina dystrophy, are not exclusionary
- Any prior treatment with anti-VEGF agents
- Intraocular surgery (including lens replacement surgery) within 3 months prior to screening
- History of laser therapy in the macular region
- Aphakia or absence of the posterior capsule. Note: Yttrium aluminum garnet laser posterior capsulotomy for posterior capsule opacification done at least 60 days prior to screening is not exclusionary.
- Any ocular condition other than GA secondary to AMD that may require surgery or medical intervention during the study period or, in the opinion of the investigator, could compromise visual function during the study period
- Any contraindication to IVT injection
- Current ocular or periocular infection in either eye
- Intravitreal medical device placement
- Participation in any prior or current systemic experimental treatment within 6 weeks or 5 half lives of the active ingredient (whichever is longer) prior to the start of study treatment or in any other investigational treatments specific to GA. Clinical trials solely involving observation, over-the-counter vitamins, supplements, or diets are not exclusionary
- Medical or psychiatric conditions that, in the opinion of the investigator, make consistent follow-up unlikely or would make the patient an unsafe study candidate
- Known hypersensitivity to fluorescein sodium for injection or hypersensitivity to pegcetacoplan or any of the excipients in pegcetacoplan solution
- History or current use of brolucizumab and/or pharmacological treatments that gain approval for the treatment of GA
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): NCT06161584
Contacts
| Contact: Apellis Clinical Trial Information Line | 617-977-5700 | clinicaltrials@apellis.com |
Locations
Show 28 study locations
Sponsors and Collaborators
Apellis Pharmaceuticals, Inc.
| Responsible Party: | Apellis Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT06161584 |
| Other Study ID Numbers: |
APL2-GA-411 |
| First Posted: | December 8, 2023 Key Record Dates |
| Last Update Posted: | February 21, 2024 |
| Last Verified: | February 2024 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Macular Degeneration Geographic Atrophy Atrophy Retinal Degeneration |
Retinal Diseases Eye Diseases Pathological Conditions, Anatomical |