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Eligibility depends on the named study
Optogenetic retinal therapies aim to make surviving retinal cells respond to light after photoreceptors have been badly damaged. GS030 combines an intravitreal gene-therapy product, GS030-DP, with light-stimulation glasses, GS030-MD. The EU Clinical Trials Information System (CTIS) record describes GS030 as investigational and not authorized. When checked on 7 October 2026, it was listed as ongoing and recruiting, with 18 participants planned at one site in one country. Recruitment and authorization status can change, so confirm them with the CTIS record and study team.
GS030 criteria are specific to its protocol
The CTIS record lists an age range of 18 to 75 years and non-syndromic RP established through clinical history, mid-peripheral visual dysfunction and funduscopic appearance, or confirmed by full-field ERG. Visual-acuity criteria differ by cohort: dose-escalation cohorts require vision no better than light perception, while an extension cohort allows no better than counting fingers, subject to review of earlier cohort data. The protocol also calls for relatively preserved ganglion-cell-layer volume and retinal nerve-fiber-layer thickness on spectral-domain OCT; its exact wording is “Relatively preserved ganglion cell layer volume and retinal nerve fiber layer thickness, as measured with spectral domain optical coherence tomography (SD-OCT).”
Other listed requirements include a history of former useful vision, adequate pupil dilation, and the ability to use the device and tolerate repeated light stimuli. These criteria do not establish who qualifies for other optogenetic studies.
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What tests and checks may be needed?
For GS030, screening assesses the diagnosis, the condition of the eye, functional vision, and whether participation is medically and practically safe. The study’s stated diagnostic routes are clinical assessment or full-field ERG confirmation; its record does not identify genetic testing as a universal requirement.
- Diagnosis and history: Review of disease course, prior useful vision, and clinical findings. The protocol also accepts full-field ERG confirmation of RP.
- Visual acuity: Measurement of remaining vision against the cohort-specific thresholds. These cutoffs are not general rules for optogenetic therapy.
- Retinal structure: Spectral-domain OCT to assess ganglion-cell-layer volume and retinal nerve-fiber-layer thickness, including whether the relevant inner retinal structures remain.
- Eye examination and dilation: Examination of the retina and other ocular structures, with sufficient pupil dilation. The protocol excludes some media problems, retinal conditions, inflammation, and histories or procedures that could interfere with vision or assessments.
- Functional vision: Measures listed as study outcomes include Freiburg visual-acuity and contrast testing (FrACT), Humphrey visual-field testing, full-field threshold stimulus testing, grating acuity, square localization, direction-of-motion, door and line tasks, and shape-perception tests. These are outcome measures; the record does not establish that every one is an entry test.
- Safety and participation: The protocol includes HIV and, where applicable, pregnancy testing, as well as review of health, medications, refractive error and interpupillary distance. Participants must be able to follow visits and device instructions.
Reasons a person may not qualify
The GS030 protocol lists exclusions including certain prior gene therapies or recent investigational treatments; relevant systemic illness; some photosensitizing or immunosuppressive medications; pregnancy or breastfeeding; HIV positivity; inability to meet follow-up obligations; and certain ocular histories or findings. These include significant eye surgery or retinal laser history, active inflammation or infection, important macular or retinal conditions, and inability to demonstrate the relevant inner retinal layer. The full criteria and their interpretation belong to the study team; an individual item alone may not determine the outcome.
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Do not confuse imaging studies or other interventions with treatment eligibility
EyeConic is an observational study
The UCSF listing for EyeConic describes an observational retinal-imaging study intended to prepare for possible cone-optogenetics research. It lists people with generalized inherited retinal dystrophy, visual acuity of 20/400 or worse in the study eye, and available macular OCT. The study aims to estimate how often dormant cone cell bodies remain; it is not a treatment study. The listing, last updated July 2025, expected 1,000 participants and estimated completion in December 2026. See the UCSF Clinical Trials listing for current details.
Other optogenetic programs are not interchangeable
AbbVie lists its AGN-151597 program, formerly RST-001, as complete. The company says participants in its phase 1 and 2a cohorts had hand-motion vision or worse and that efficacy was not demonstrated in those cohorts. That result does not establish the effectiveness of GS030 or every optogenetic approach; see AbbVie’s study information.
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A retinal-implant study may also assess whether ganglion cells and the optic nerve function, but an implant is a different intervention. Its eligibility rules should not be applied to an optogenetic trial.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.How to prepare for a screening discussion
- Ask a retinal-dystrophy specialist to review your diagnosis and the exact study you are considering.
- Gather existing OCT and ERG reports, visual-acuity records, and information about prior eye procedures and gene therapies.
- Ask the study team to explain its current inclusion and exclusion criteria, screening tests, visit schedule, device requirements, and whether records can be reviewed before travel.
- Check the registry and investigators for current site availability and recruitment status before making plans.
When comparing studies, focus on the required diagnosis, target retinal cells and OCT findings, baseline vision, diagnostic confirmation, procedure and device, safety exclusions, site access, and study phase and status. A specialist and the investigators must determine whether your records fit a particular protocol; screening does not guarantee enrollment, treatment, or benefit.
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