SOL-X
A SOL-R participant successfully reaches Week 96 and otherwise appears ready for SOL-X, but had prior intraocular inflammation in the study eye. Can they enroll?
No. A history of intraocular inflammation in the study eye is a SOL-X exclusion criterion.
This Phase 3 Merck study evaluates MK-8748 in participants with what retinal condition?
Diabetic macular edema, or DME.
A participant meets DRA criteria at Week 16. What happens to their dosing interval, and when is the next time DRA is assessed?
Their interval shortens from Q16W to Q8W, and they do not undergo another DRA assessment until Week 28. The same applies if DRA is first met at Week 20.
WOCBP
Woman/Women of Childbearing Potential
What is SOP
Standard Operating Procedure
Which types of assessments may not need to be repeated, and what Day 1 CFP requirement still applies after treatment?
Safety labs and imaging may not need to be repeated. Pre-injection CFP may not need repeating, but post-injection CFP must still be performed after OTX-TKI administration.
Name the three treatment arms in MK-8748-005.
MK-8748 7 mg, MK-8748 10 mg, and aflibercept 2 mg.
A participant does not meet DRA criteria at Weeks 16 or 20, but does meet the criteria at Week 24. What becomes their new maintenance interval?
Q12W.
ADA
Anti-Drug Antibody
SUSARs, SADRs, IBs, investigator letters, and medical monitor memos are examples of these.
What are safety documents?
A participant completes SOL-1 or SOL-R and is entering SOL-X. How long do they have to complete SOL-X Day 1?
Day 1 should occur within 45 days of the parent-study final visit.
All three treatment groups start on the same dosing schedule. What is the schedule through Week 48?
Five initial Q4W injections at Day 1 and Weeks 4, 8, 12, and 16, followed by Q8W dosing at Weeks 24, 32, 40, and 48.
Beginning at Week 28, a participant is already on Q8W and meets DRA criteria again. What happens at that visit, and what becomes the next dosing interval?
They are dosed at that visit, and the next interval is shortened by 4 weeks from Q8W to the protocol minimum of Q4W.
eCRF
Electronic Case Report Form
How often must GCP training, IATA/biological shipping training, and RCA SOP refresher training be completed?
GCP at least every 3 years; IATA/biological shipping at least every 2 years; SOP refresher training at least every 2 years.
OTX-TKI is administered at an unscheduled SOL-X visit. What three post-injection assessments are specifically called out by the protocol?
Post-injection IOP, CFP, and implant visualization assessment.
Starting at Week 48, what must happen before an MK-8748 participant can begin personalized treatment intervals, and what are the shortest and longest allowed intervals?
CST must reach <325 µm. PTI can range from Q8W to Q16W based on BCVA and CST response. Aflibercept participants remain Q8W.
A participant presents with an ocular/periocular infection on a scheduled dosing visit. How long may treatment be delayed at Weeks 4 or 8 versus a maintenance visit, and does that delay move the rest of the dosing schedule?
Up to 3 days at Weeks 4 and 8 and up to 5 days at maintenance dosing visits. No—the later doses remain on the original schedule relative to the first dose.
SUSAR
Suspected Unexpected Serious Adverse Reaction
Copies made for auditors or inspectors should be certified and have this information redacted when appropriate.
PHI
A participant never needed rescue in SOL-R and now enters SOL-X. Compare the BCVA/CSFT pathway for their first supplemental injection in the two studies: what CSFT threshold changed?
SOL-R uses >5 letters lost plus ≥75 µm CSFT increase; SOL-X uses >5 letters lost plus ≥50 µm CSFT increase. The alternative pathway is new or worsening vision-threatening hemorrhage.
Why does the study begin using sham injections in Year 2 even though no sham is required during Year 1?
During Year 1, all three arms follow the same dosing schedule, so sham is unnecessary. After Week 48, MK-8748 participants may move to individualized treatment intervals while aflibercept stays Q8W. Beginning Week 56, IRT assigns sham injections at visits without active treatment to preserve masking.
A participant enrolled in the PK substudy develops a clinical need for fellow-eye anti-VEGF treatment before the Day 29/Week 4 predose PK sample. What happens to their PK-substudy participation and their main-study participation?
After fellow-eye treatment, no further PK-substudy samples are collected and the participant discontinues the PK substudy. They remain in the main study and continue main-study PK sampling per the SoA.
NEI-VFQ-25
National Eye Institute 25-Item Visual Function Questionnaire
What is the difference between the FDA 482 form and FDA 483 form?
FDA Form 482 — Notice of Inspection: Presented at the start of the inspection. FDA Form 483 — Inspectional Observations: Issued after the inspection if the FDA investigator identifies conditions or practices they believe may violate FDA requirements.