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There is no single eligibility checklist for optogenetic therapy. Qualification depends on the exact clinical trial. One investigational study of GS030 is aimed at adults with advanced, non-syndromic retinitis pigmentosa (RP), very severe vision loss, and evidence that key inner retinal cells remain. Screening may include visual-acuity tests, retinal examination, OCT, electroretinography, functional-vision tasks, and medical safety checks. A retinal specialist and the study team must assess whether someone fits that protocol; screening does not guarantee enrollment or benefit.
Why eligibility depends on the specific trial
Optogenetic approaches seek to make surviving retinal cells respond to light after photoreceptors have been severely damaged. The GS030 study combines an intravitreal gene-therapy product, GS030-DP, with light-stimulation glasses, GS030-MD. In the EU Clinical Trials Information System (CTIS) record, the product is listed as not authorized. The record described the study as ongoing and recruiting when accessed on 7 October 2026; it planned 18 participants at one site in one country. Status and recruitment can change, so check the CTIS record and ask the study team for current details.
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The GS030 criteria are not universal rules for optogenetic treatment. Other studies may target different retinal cells, accept different diagnoses or vision levels, and use different tests and exclusions.
Who the GS030 study may consider
The CTIS protocol describes adults aged 18 to 75 with non-syndromic RP. The diagnosis may be established from clinical history, mid-peripheral visual dysfunction and fundus appearance, or confirmed by full-field electroretinography (ERG). The study also requires very severe vision loss, while the exact visual-acuity threshold depends on the cohort:
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- Dose-escalation cohorts: vision no better than light perception.
- Extension cohort: vision no better than counting fingers, subject to review of data from earlier cohorts.
Potential participants must also have relatively preserved ganglion-cell-layer volume and retinal nerve-fiber-layer thickness on spectral-domain optical coherence tomography (SD-OCT). These inner retinal structures matter because the approach depends on surviving retinal cells. The protocol further specifies a history of former useful vision, adequate pupil dilation, and ability to use the glasses and tolerate repeated light stimulation.
The CTIS eligibility record does not identify a genetic test as a universal requirement for GS030: it lists clinical assessment or full-field ERG confirmation as diagnostic routes. A different trial may require a genetic diagnosis, so ask about the named protocol.
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Tests and checks screening may involve
Diagnosis and vision level
The team may review the disease history, prior useful vision and retinal findings, then measure visual acuity. For GS030, full-field ERG is one possible way to confirm RP, and the required acuity threshold varies by cohort. These thresholds apply to that study, not to every optogenetic trial.
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SD-OCT is used to assess the ganglion-cell layer and retinal nerve-fiber layer. A comprehensive eye examination may also assess whether the pupil dilates sufficiently and whether other retinal or eye conditions could interfere with treatment or reliable testing.
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Functional vision measures
The GS030 record lists outcome measures including Freiburg visual-acuity and contrast testing (FrACT), Humphrey visual-field testing, full-field threshold stimulus testing, grating acuity, square localization, direction-of-motion tasks, door and line tasks, and shape-perception tests. These measures assess visual function; their appearance in the record does not mean every one is necessarily an entry test.
Health, safety and practical review
Screening criteria include HIV and pregnancy testing where applicable, along with review of health conditions and medications. The protocol also specifies limits involving refractive error and interpupillary distance, and checks whether a participant can attend follow-up visits and follow device instructions.
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Reasons someone may not meet this protocol
The GS030 record lists exclusions that can involve prior gene therapy or recent investigational treatment; relevant systemic illness; certain photosensitizing or immunosuppressive medicines; pregnancy or breastfeeding; HIV positivity; inability to complete follow-up; significant eye surgery or retinal laser history; active eye inflammation or infection; important macular or retinal conditions; or insufficient evidence of the relevant inner retinal layer. The study team interprets the full criteria in context, so this is not a personal eligibility checklist.
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Do not confuse an imaging study with a treatment trial
EyeConic, an observational retinal-imaging study listed by UCSF, is preparing for possible cone-optogenetics research; it is not itself a treatment study. Its listing describes people with generalized inherited retinal dystrophy, visual acuity of 20/400 or worse in the study eye, and available macular OCT. It aims to estimate how often dormant cone cell bodies remain. UCSF listed 1,000 expected participants and estimated completion in December 2026; those figures are from its listing last updated July 2025. See the UCSF study listing.
A separate AbbVie program, AGN-151597 (formerly RST-001), is listed as complete. AbbVie reports that all Phase 1 and 2a participants had hand-motion vision or worse and that efficacy was not demonstrated in those cohorts. That result does not establish whether GS030 or other optogenetic approaches are effective. See AbbVie’s pipeline information. Criteria from retinal-implant studies should not be transferred to optogenetic trials: an implant is a different intervention.
How to prepare to ask about eligibility
- Ask a retinal-dystrophy specialist to review your diagnosis, current visual acuity, prior useful vision and relevant eye history.
- Gather existing OCT and ERG reports, records of eye procedures, and information about previous gene therapies or investigational treatments.
- Identify the specific optogenetic trial and compare its diagnosis requirements, acuity threshold, OCT findings, tests, safety exclusions, device or procedure, study phase, site and current recruitment status.
- Contact the study team to ask whether it can review your records before you travel and whether the site is still enrolling.
The investigator makes the final eligibility decision under the protocol. Even when a person qualifies and enrolls, participation does not guarantee that the treatment will improve vision.
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