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. 2023 Jun 14;2023(6):CD009300. doi: 10.1002/14651858.CD009300.pub3

NCT04643886.

Study name A multiple dose study of repeat intravitreal injections of GEM103 in dry age‐related macular degeneration
Methods Phase 2a, open‐label, multiple dose study at multiple centres
Participants Adults 50 years and older with GA due to AMD and BCVA of 24 to 83 letters on the ETDRS chart. All participants must have one of the two pre‐specified genetic profiles. Participants with prior history of exudative AMD or CNV are excluded.
Interventions GEM103 administered as repeat intravitreal injections in participants with Genetic Profile A as compared to participants with Genetic Profile B
Outcomes Primary outcome measure:
  • Safety of IVT injections of GEM103, as measured by number of participants with ocular adverse events (time frame: 18 months)


Secondary outcome measures:
  • Change in BCVA as assessed by ETDRS chart (time frame: 6 months)

  • Total CFH levels in aqueous humour after GEM103 IVT injection (time frame: 6 months)

Starting date November 2020
Contact information Gemini Therapeutics Inc., MA, USA
Status Terminated (no further benefit)
Required reporting date February 2023
Notes