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Gene Therapy

BIIB111 for Choroideremia & BIIB112 for X-Linked Retinitis Pigmentosa (SOLSTICE Trial)

Phase 3
Waitlist Available
Research Sponsored by NightstaRx Ltd, a Biogen Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
a. Have received a sub-retinal injection of BIIB112 for XLRP and have exited an antecedent study.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

SOLSTICE Trial Summary

This trial will compare the long-term safety and efficacy of a sub-retinal injection of BIIB111 in participants with Choroideremia (CHM) who have been previously treated with BIIB111, with untreated control participants who have exited the STAR (NCT03496012) study. The trial will also compare BIIB112 in participants with X-linked retinitis pigmentosa (XLRP) who have been previously treated with BIIB112.

Who is the study for?
This trial is for individuals with Choroideremia (CHM) or X-linked Retinitis Pigmentosa (XLRP) who have previously received BIIB111 or BIIB112 treatments in earlier studies. Participants must have completed the prior research to be eligible.Check my eligibility
What is being tested?
The study aims to assess the long-term safety and effectiveness of sub-retinal injections of BIIB111 for CHM and BIIB112 for XLRP by comparing previously treated participants with untreated controls from a related study.See study design
What are the potential side effects?
While specific side effects are not listed, they may include typical reactions associated with sub-retinal injections such as eye discomfort, inflammation, possible vision changes, and risks associated with intraocular procedures.

SOLSTICE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had a BIIB112 injection for XLRP and completed a prior study.

SOLSTICE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ophthalmic Examination Assessment: Abnormal Slit Lamp Examination
Ophthalmic Examination Assessment: Anterior Chamber and Vitreous Inflammation
Ophthalmic Examination Assessment: Indirect Ophthalmoscopy
+3 more
Secondary outcome measures
Assessment of Fundus Autofluorescence (AF) at Each Visit
Assessment of Fundus Photography at Each Visit
Assessment of Microperimetry at Each Visit
+9 more

SOLSTICE Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: BIIB112Experimental Treatment1 Intervention
Participants previously treated with sub-retinal injection of BIIB112 in the antecedent study 274RP101 (NCT03116113) will be enrolled. This is a follow-up study, investigational product was administered in the previous study.
Group II: BIIB111Experimental Treatment1 Intervention
Participants previously treated with sub-retinal injection of BIIB111 in antecedent studies 273CH301 (NCT03496012) and 273CH203 (NCT03507686) will be enrolled. Participants previously treated with this same sub-retinal injection (rAAV2-REP1) in antecedent studies 20150371 (NCT02553135), Pro00028599 (NCT02077361), THOR-TUE-01 (NCT02671539), CHM09/01 (NCT01461213) and REGEN2015 (NCT02407678) will also be invited for enrollment. This is a follow-up study, investigational product was administered in the previous study.
Group III: UntreatedActive Control1 Intervention
Untreated participants who served as controls in the antecedent study 273CH301 (NCT03496012), investigating treatment with BIIB111, will be enrolled. This is a follow-up study, participants will not be administered study medication nor receive a sham surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BIIB111
2017
Completed Phase 3
~240
BIIB112
2017
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

NightstaRx Ltd, a Biogen CompanyLead Sponsor
5 Previous Clinical Trials
805 Total Patients Enrolled
3 Trials studying Choroideremia
554 Patients Enrolled for Choroideremia
Medical DirectorStudy DirectorBiogen
2,777 Previous Clinical Trials
8,063,150 Total Patients Enrolled
5 Trials studying Choroideremia
1,778 Patients Enrolled for Choroideremia

Media Library

BIIB111 (Gene Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03584165 — Phase 3
Choroideremia Research Study Groups: BIIB111, BIIB112, Untreated
Choroideremia Clinical Trial 2023: BIIB111 Highlights & Side Effects. Trial Name: NCT03584165 — Phase 3
BIIB111 (Gene Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03584165 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many total research centers are participating in this clinical trial?

"There are 13 sites where this study is enrolling patients. A few locations include New york, Montreal and Edmonton with 10 other facilities. If you choose to participate in this trial, selecting the location nearest to you will reduce travel-related costs."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
Texas
How old are they?
18 - 65
< 18
What site did they apply to?
Research Site
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I want to be part of your research and hoping we can beat this blinding condition.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Long-term Safety and Efficacy Follow-up of BIIB111 for the Treatment of Choroideremia and BIIB112 for the Treatment of X-Linked Retinitis Pigmentosa
2018. "Long-term Safety and Efficacy Follow-up of BIIB111 for the Treatment of Choroideremia and BIIB112 for the Treatment of X-Linked Retinitis Pigmentosa". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03584165.
All > Choroideremia > Retinitis Pigmentosa
~86 spots leftby Jun 2026
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