Three-Year Data Show Vision Gains Maintained With Subretinal Implant

Clinical Scorecard: Three-Year Data Show Vision Gains Maintained With Subretinal Implant

At a Glance

Category	Detail
Condition	Geographic atrophy
Key Mechanisms	The PRIMA photovoltaic implant is placed beneath the retina; camera-equipped glasses project a signal to the implant, which reaches surviving bipolar and ganglion cells and the brain.
Target Population	Patients with geographic atrophy enrolled in the PRIMAvera trial; 38 patients were enrolled at 17 centers across Europe.
Care Setting	Surgical implantation followed by vision rehabilitation and longitudinal clinical-trial follow-up.

Key Highlights

At 3 years, vision with the device averaged about 20/120 among 18 patients evaluated, compared with an average of roughly 20/460 at study start.
Fourteen of 18 patients evaluated at 3 years improved by at least 2 lines; the same proportion improved by at least 3 lines.
With the device switched off, vision in implanted eyes remained essentially unchanged over 3 years.
Three patients each experienced one serious eye-related adverse event between months 13 and 36; most serious complications occurred in the first year and were linked to surgery.
The trial had no control group; at 36 months, 27 of 38 patients were evaluable for safety and 18 for efficacy.

Guideline-Based Recommendations

Diagnosis

Management

Patients underwent PRIMA implantation followed by vision rehabilitation to learn to use the system.

Monitoring & Follow-up

The trial reported safety and efficacy follow-up through 36 months.

Risks

Most serious complications occurred during the first year and were linked to implant surgery.
Between months 13 and 36, three patients each had one serious eye-related adverse event.

Patient & Prescribing Data

PRIMAvera enrolled 38 patients with geographic atrophy at 17 European centers. At 36 months, 27 were evaluable for safety and 18 for efficacy.

Among 18 patients evaluated at 3 years, average vision with the device was about 20/120; 14 of 18 improved by at least 2 lines. Vision in implanted eyes with the device off remained essentially unchanged over 3 years.

Clinical Best Practices

Provide vision rehabilitation after implantation so patients can learn to use the camera-equipped glasses and implant system.
Assess vision with the device on and off, as reported in the trial.
Monitor for eye-related adverse events during follow-up, including those associated with implantation surgery.