Application — Other
PRIMAvera pivotal study of the PRIMA subretinal implant in geographic atrophy (NCT04676854)
Lab or organization
PRIMAvera pivotal study in geographic atrophy (NCT04676854)
The pivotal European study of Science Corporation’s PRIMA subretinal photovoltaic implant, published in the New England Journal of Medicine. Registry facts are from ClinicalTrials.gov and the paper (verified October 25, 2026); results after the 12-month paper are company-reported and labeled as such.
Study facts
| Field | Value and source scope |
|---|---|
| Registry | NCT04676854; interventional, single-group, no masking, treatment purpose [1] |
| Official title | Restoration of Central Vision With the PRIMA System in Patients With Atrophic AMD [1] |
| Sponsor | Science Corporation [1] |
| Status | Active, not recruiting: actual start November 24, 2020, estimated completion March 2029 (long-term follow-up) [1] |
| Enrollment | 38 (estimated) [1]; the paper reports 38 implanted at 17 sites in 5 European countries, 32 reaching 12 months, mean age 78.9 [2] |
| Conditions | Geographic atrophy from age-related macular degeneration; age 60 or older, visual acuity logMAR 1.2 or worse, fovea-involving atrophy larger than 2.4 mm [2] |
| Publication | N Engl J Med 2025;394(3):232-242, published online October 20, 2025 [2][3] |
| Primary outcome | 26 of 32 participants (81.3%; 95% CI 63.56 to 92.79) improved visual acuity by at least logMAR 0.2 at 12 months; with the camera glasses, mean improvement was logMAR 0.49 (about 24.5 letters) [2] |
| Prosthetic acuity | logMAR 1.32 (about 20/417), matching the 100 um pixel sampling limit [2] |
| Key limitations | Single-arm, open-label. 26 serious adverse events in 19 participants, 81% within the first two months. Three of the six participants who did not reach 12 months died. Mean atrophy area grew 8.5 mm2 in study eyes versus 2.5 mm2 in fellow eyes [2] |
| Earlier feasibility trial | Five participants; three reliably recognized letter sequences, acuity near the 20/420 pixel limit, mean 20/135 at 4 years (cited in the paper) [2] |
Company-reported updates (labeled)
- CE mark under the EU Medical Device Regulation and European commercial launch announced July 22, 2026; US FDA review pending with Breakthrough Device and Humanitarian Use Device designations [4].
- 36-month PRIMAvera results announced October 5, 2026 [5]. These releases are company statements; the device sheet carries the details.
Primary sources
- ClinicalTrials.gov, NCT04676854. Verified October 25, 2026.
- N Engl J Med 2025;394(3):232-242, subretinal photovoltaic implant (PMC full text).
- Crossref record, DOI 10.1056/NEJMoa2501396.
- Science Corporation, European commercial launch and CE mark, July 22, 2026. Company press release.
- Science Corporation, 36-month PRIMAvera results, October 5, 2026. Company press release.