EXPLORE: A phase 2, outcomes assessor-masked, multicentre, randomised study to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with geographic atrophy secondary to age-related macular degeneration

Gyroscope Therapeutics0 个研究点目标入组 54 人开始时间: 2019年11月22日最近更新: 2024年6月3日

适应症

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•1. Able and willing to give written informed consent
•2. Age =18 years
•3. Have a clinical diagnosis of GA secondary to AMD as determined by the Investigator
•4. Have GA lesion(s) total size between or equal to 1.25mm2 to 17.5mm2 in the study eye
•5. The GA lesion in the study eye must reside completely within the FAF image
•6. Have a BCVA of 34 letters (6/60 and 20/200 Snellen acuity equivalent) or better, using ETDRS charts, in the study eye
•7. Serum CFI level less than the lower limit of the normal range (11.6 to 35.7 mcg/mL) on an Enzyme-linked immunosorbent assay
•8. Have a rare genetic variant of the CFI gene, defined as a minor allele frequency of <1%
•9. Able to attend all study visits and complete the study procedures
•10. Women of child-bearing potential must have a negative pregnancy test within 2 weeks prior to randomisation
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 27
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 27

•1. Have evidence or history of CNV or diabetic retinopathy in either eye
•2. Have history of vitrectomy, sub-macular surgery, or macular photocoagulation in the study eye
•3. Have clinically significant cataract that may require surgery during the study period in the study eye
•4. Have any other significant ocular or non-ocular medical or psychiatric condition which, in the opinion of the Investigator, may either put the subject at risk or may influence the results of the study
•5. Have a contraindication to oral prednisolone/prednisone
•6. Have participated in another research study involving an investigational product in the previous 12 weeks, or five half-lives, whichever is longer, or received a gene or cell therapy at any time
•7. Are unwilling to use two forms of contraception (one of which being a barrier method) for 90 days post-dosing, if relevant
•8. Have a history or presence of cutaneous squamous cell carcinoma

发起方

Gyroscope Therapeutics