All > Age Related Macular Degeneration > Geographic Atrophy

PRIMA for Age-Related Macular Degeneration

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UPMC Eye Center, Pittsburgh, PAAge-Related Macular DegenerationPRIMA - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new retinal prothesis for safety and performance in subjects with dry age related macular degeneration.

Eligible Conditions
  • Age-Related Macular Degeneration (AMD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
ASP7317
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Part B High dose
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Iptacopan (LNP023)

Study Objectives

0 Primary · 4 Secondary · Reporting Duration: 3, 6, 9, 12, 18, 24 and 36 months after implantation

Month 36
Quality of Life
Month 36
Visual Acuity
Month 36
Near Visual Acuity
Month 36
Reading Acuity Test

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
ASP7317
1
Part B High dose
2
Iptacopan (LNP023)

Trial Design

1 Treatment Group

PRIMA
1 of 1

Experimental Treatment

5 Total Participants · 1 Treatment Group

Primary Treatment: PRIMA · No Placebo Group · N/A

PRIMA
Device
Experimental Group · 1 Intervention: PRIMA · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3, 6, 9, 12, 18, 24 and 36 months after implantation

Who is running the clinical trial?

Pixium Vision SALead Sponsor
4 Previous Clinical Trials
73 Total Patients Enrolled
Pixium Vision LLC acts as sponosor in the US on behalf of Pixium Vision SAUNKNOWN
Joseph Martel, MDPrincipal InvestigatorUPMC Pittsburgh
1 Previous Clinical Trials
150 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 37 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a chronic or recurring infection or inflammation that would prevent you from participating in the study.
You have another device implanted in your body that is currently in use.
You have a long-term or repeat inflammation or infection.
You have a serious mental health condition.
You have a severe condition affecting your kidneys, heart, liver, or other organs.
You have a cataract in your eye.
You have eye movement issues, such as nystagmus.
Your immune system is weakened.
You have an eye condition in your non-study eye that meets one of the following criteria:
You have a telescope surgically implanted in one of your eyes.
You have a history of seizures.
You have unrealistic expectations about what the study drug can do for you.
References

Frequently Asked Questions

Is there still room for potential participants to join this research?

"As per clinicaltrials.gov, this experiment is currently seeking participants. First posted on April 26th 2018 and last updated June 6th 2022." - Anonymous Online Contributor

Unverified Answer

How many participants are currently enrolled in this experiment?

"This study necessitates that 5 eligible participants enroll in the trial. Potential patients can take part from various locations such as Bascom Palmer Eye Institute in Miami, Florida and Byers Eye Institute-Stanford University in Palo Alto, California." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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