Phase 2
Completed N=21
A Study to Evaluate the Safety and Clinical Response of Subretinal Administration of CNTO 2476 in Participants With Geographic Atrophy
Visual Acuity · Geographic Atrophy · Macular Degeneration
Source: ClinicalTrials.gov NCT02659098 ↗
Enrolled (actual)
21
Serious AEs
23.8%
Results posted
Jun 2020
Primary outcomePrimary: Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 1- Treated Eye — 0.132 logMAR
Summary
The purpose of this study is to evaluate the safety and performance profile of the suprachoroidal surgical approach and the Delivery System.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 1- Treated Eye |
0.132 | — |
| PRIMARY Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 2- Treated Eye |
0.073 | — |
| PRIMARY Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 3- Treated Eye |
0.079 | — |
| PRIMARY Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 6- Treated Eye |
0.090 | — |
| PRIMARY Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 12- Treated Eye |
0.119 | — |
| PRIMARY Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 18- Treated Eye |
0.107 | — |
| PRIMARY Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 24- Treated Eye |
0.145 | — |
| PRIMARY Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 30- Treated Eye |
0.112 | — |
| PRIMARY Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 36- Treated Eye |
0.211 | — |
| PRIMARY Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 1- Fellow Eye |
0.017 | — |
| PRIMARY Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 2- Fellow Eye |
0.027 | — |
| PRIMARY Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 3- Fellow Eye |
0.010 | — |
| PRIMARY Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 6- Fellow Eye |
0.033 | — |
| PRIMARY Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 12- Fellow Eye |
0.074 | — |
| PRIMARY Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 18- Fellow Eye |
0.075 | — |
| PRIMARY Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 24- Fellow Eye |
0.115 | — |
| PRIMARY Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 30- Fellow Eye |
0.106 | — |
| PRIMARY Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 36- Fellow Eye |
0.309 | — |
| SECONDARY Percentage of Participants Losing Greater Than or Equal to (>=) 15 Best Corrected Visual Acuity Letters: Treated Eye |
14.3; 14.3; 19.0; 14.3; 16.7; 17.6 | — |
| SECONDARY Percentage of Participants Losing >=15 Best Corrected Visual Acuity Letters: Fellow Eye |
0; 0; 0; 4.8; 16.7; 17.6 | — |
| SECONDARY Change From Baseline in Best Corrected Visual Acuity Letters at Months 6 and 12: Treated Eye |
-4.5; -5.9 | — |
| SECONDARY Change From Baseline in Best Corrected Visual Acuity at Months 6 and 12: Fellow Eye |
-1.7; 6.76 | — |
| SECONDARY Change From Baseline in Growth Rate of Geographic Atrophy (GA) Lesion Area at Months 6 and 12: Treated Eye |
0.6691; 2.4214 | — |
| SECONDARY Change From Baseline in Growth Rate of Geographic Atrophy Lesion Area at Months 6 and 12: Fellow Eye |
1.2085; 2.6457 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
20; 5 | — |
| SECONDARY Number of Participants With Ocular Treatment-emergent Adverse Events |
17; 10 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) confirmed within 45 days prior to initial randomization verified by the central reading center
- Study eyes will have a best corrected visual acuity (BCVA) of 20/80 to 20/800 [Early Treatment Diabetic Retinopathy Study (ETDRS) log of the minimum angle of resolution (logMAR) value 0.6-1.6]. The treatment eye will be that with the worse BCVA at Screening. If BCVA is clinically equivalent, the eye with the larger GA determines the study eye
- Participant is a suitable candidate for ophthalmologic surgery, is willing and able to comply with the surgical procedure, scheduled visits, treatment plan, laboratory tests and other study procedures. Participant has met criteria of the surgery center anti-coagulation protocol, if applicable
- Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study
Exclusion Criteria
- Participant has a history of neovascular ("wet") AMD in the treatment eye, including evidence of retinal pigment epithelium rips or evidence of subretinal or choroidal neovascularization or fluid. In cases where imaging is inconclusive, review of the case with the study site, considering history and imaging will determine eligibility. History or evidence of neovascular AMD in the fellow eye is allowed, if anti-vascular endothelial growth factor (VEGF) therapy has not been required for at least 8 weeks prior to Screening
- Geographic atrophy secondary to any causes other than AMD in either eye
- A diagnosis of glaucoma with an intraocular pressure (IOP) greater than or equal to (>=) 25 millimeter of mercury (mmHg) while being treated with an ocular hypotensive drug. Treatment should be no more than 1 drug preparation/combination, which can contain 1 or 2 ocular hypotensive active ingredients; participants receiving more than 2 ocular hypotensive active ingredients are excluded
- Nuclear sclerotic cataract, cortical spoking, posterior subcapsular cataract above Grade 2 per Age Related Eye Disease Study (AREDS) scale or any other ophthalmologic condition that reduces the clarity of the media that, in the opinion of the investigator or reading center, interferes with ophthalmologic examination (example, corneal abnormalities, inadequate pupillary dilation), surgery or imaging in the study eye
- Myopia greater than minus (>-) 8 diopters and participants with greater than (>) 4 diopters of astigmatism, and greater than plus (>+) 10 diopters of hyperopia
Data sourced from ClinicalTrials.gov (NCT02659098). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.