Product information and disease description Product description Product information

Special populations

7 evidence topics · 5 sources

Age range studied

Study	Quoted criterion
SOL-1	“50 Years and older (Adult, Older Adult )”

“Ages Eligible for Study 50 Years and older (Adult, Older Adult )” (opens the source at this quote in a new tab)

“50 Years to 100 Years (Adult, Older Adult )” (opens the source at this quote in a new tab)

Age of randomized participants in SOL-1

“Age, years, mean (SD) 75.7 (8.3) 76.3 (7.4)” (opens the source at this quote in a new tab)

Pregnancy, breastfeeding, and contraception: SOL-X exclusion criterion

“Female participants who are pregnant (had a positive urine test at the Baseline visit [Day 1]) or breastfeeding or intend to become pregnant during the study, who are unwilling to use 2 forms of highly effective contraception from baseline until they exit the study or at least 3 months after the last study treatment, whichever is later.” (opens the source at this quote in a new tab)

Contraception in the Australian phase 1 trial

“Are female who is postmenopausal for at least 12 months prior to screening or surgically sterile; or male or female of childbearing potential willing to use two forms of adequate contraception” (opens the source at this quote in a new tab)

Monocular patients and fellow-eye vision: exclusion criteria

“Monocular subjects or a Best Corrected Visual Acuity (BCVA) score of 20/200 in fellow eye at screening.” (opens the source at this quote in a new tab)

Advanced lesions with scar, fibrosis, or atrophy: exclusion criterion

“Have evidence of a scar, fibrosis, or atrophy of > 50% of the total lesion in the study eye.” (opens the source at this quote in a new tab)

Prior intraocular inflammation: SOL-X exclusion criterion

“History of intraocular inflammation in the study eye” (opens the source at this quote in a new tab)

Pediatric use, renal or hepatic impairment, and lactation data for the implant

No evidence found.