Clinical trial NCT05626114: A Study to Optimize Subretinal Surgical Delivery and to Evaluate Safety and Activity of Opregen in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (GAlette)
Official title: A Phase IIa, Multicenter, Open-Label, Single-Arm Study To Optimize Subretinal Surgical Delivery And To Evaluate Safety And Activity Of Opregen In Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Geographic Atrophy
Keywords: Geographic Atrophy secondary to Age-related Macular Degeneration
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2022-11-23
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the success and safety of subretinal surgical delivery as well as the preliminary activity of OpRegen in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). All endpoints are assessed for the study eye unless otherwise indicated


Eligibility criteria: Inclusion Criteria:

* Ability to undergo a vitreoretinal surgical procedure under monitored anesthesia care
* Diagnosis of GA secondary to AMD
* BCVA score \>/= 29 letters and \</= 60 letters in the study eye as assessed by ETDRS
* Pseudophakic (study eye)

Exclusion Criteria:

* Pregnancy or breastfeeding
* History of cognitive impairment or dementia
* Any type of systemic disease or its treatment, in the opinion of the investigator, including any medical conditions that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the participant to a significant degree or put the participant at special risk

Ocular Exclusion Criteria for Study Eye:

* Any current or history of ocular disease other than GA that may confound assessment of the macula
* History of retinal detachment
* History of vitrectomy, glaucoma-filtering surgery, or corneal transplant
* Uncontrolled glaucoma or advanced glaucoma
* Any cataract surgery or intraocular surgery within 3 months prior to subretinal surgical delivery of OpRegen
* History of other ocular or intraocular conditions that contraindicate the use of an investigational drug or may affect interpretation of the study results or may render the participant at high risk for treatment complications
* Any existing posterior segment device or implant

Primary outcomes:
measure: Proportion of Patients With Subretinal Surgical Delivery of OpRegen to Target Regions
timeFrame: 3 months post surgery
measure: Incidence and Severity of Procedure-related Adverse Events at 3 Months Following Surgery
timeFrame: 3 months post surgery
Secondary outcomes:
measure: Proportion of Patients With Qualitative Improvement in Retinal Structure, as Determined by OCT Imaging Within 3 Months Following Surgery
timeFrame: 3 months post surgery
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Retina-Vitreous Associates Medical Group
state: California
city: Sacramento
country: United States
facility: Retinal Consultants Medical Group
state: California
city: San Francisco
country: United States
facility: West Coast Retina
state: California
city: Blue Ash
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Philadelphia
country: United States
facility: Mid Atlantic Retina
state: Pennsylvania
city: Jerusalem
country: Israel
facility: Hadassah MC
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky MC
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: