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The trial is taking place at:
R

Retinal Consultants Medical Group | Greenback Lane, Sacramento, CA

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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

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Genentech

Status and phase

Enrolling
Phase 2

Conditions

Geographic Atrophy

Treatments

Biological: OpRegen

Study type

Interventional

Funder types

Industry

Identifiers

NCT05626114
GR44251

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Ability to undergo a vitreoretinal surgical procedure under monitored anesthesia care
  • Diagnosis of GA secondary to AMD
  • BCVA score >/= 35 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 patient to a significant degree or put the patient 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 patient at high risk for treatment complications

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

OpRegen
Experimental group
Description:
OpRegen dose up to approximately 200,000 cells will be delivered into the subretinal space
Treatment:
Biological: OpRegen

Trial contacts and locations

5

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Central trial contact

Reference Study ID Number: GR44251 https://forpatients.roche.com/

Data sourced from clinicaltrials.gov

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