Unit 4 - AMD Clinical trials Flashcards
Which trial compared PDT to Lucentis?
- Letters were gained with Lucentis
- 90% avoided >15 letters of vision
- 1/3 of eyes gained >15 letters at 2 years
Which study compared Lucentis to Sham in both occult and classic CNVM?
Marina, same results as Anchor
Following Anchor and Marina which trial looked at giving two different strengths of Lucentis at a 0,4,8, weeks then 3 monthly
Pier, 90% avoided vision loss but eyes did not gain significant vision
Which trial led to the adoption of a prn basis of Lucentis and why?
Pronto, showed that after 3 loading doses prn was as effective but with less injections
Which trial showed that Lucentis produced more GA that Avastin?
CATT, compared Lucentis prn or monthly to Avastin prn or monthly.
Which trial compared Eylea to Lucentis?
View 1 and 2
Which trial compared anti-VEGF to PDT for Myopic CNVM
Radiance
Showed a 10 letter increase compared to just 2 letters with PDT
Which trial compared anti-VEGF to sham treatment for myopic CVNM?
up 13 letters versus 4 with just 2 injections
What did Bolt compare?
Avastin to macula laser for DMO
Bolt (avastin to laser)
Which trial compared ozurdex to a sham injection for DMO?
MEAD, average number of implants was just 4 over 3 years but more cataracts.
Which trial compared illuvien in two concentrations to sham for DMO?
Fame! Illuvien worked and maintained va for 3years BUT incidence of cataracts and high IOPs was higher.
Which trial compared lucentis with lucentis + laser and sham injection+ lase for DMO?
RESTORE, lucentis with or without laser resulted I. 40% gaining 10 letters and 23% more than 15 letters.
What did the drcr .net trial look at?
lucentis + prompt or delayed laser versus illuvien + prompt or delayed laser
- lucentis gained most letters
- prompt laser plus lucentis resulted in fewer injections
Which trial compared two strengths of lucentis versus sham injection?
- Rise and ride
- 42% gained more than 15 letters + general improvement in DR.
What did vivid and vista look at?
eylea 4 weekly or 8 weekly versus laser treatment. Both Eylea groups gained significant bcva. No difference between 4 or 8weekly + significant improvement in DR.
What current treatments are being looked at for wet amd?
Harrier, brolucizumab, currently in phase 3 against Eylea
Sequoia and Cedar, phase 3 looking at DARPins, being compared against lucentis 4 weekly.
What drug is being investigated to treat RPE65 retinal dystrophy?
luxturna 425k dollars per eye
What did the Mahalo trial look at?
Lampalizumab, for ga - failed to deliver.
What is the macustar treatment looking at?
looking at intermediate amd and its progression into late amd. In particular which investigations in addition to photography gives the best idea of ga development.
What is phase 0?
- Investgates pharmacokinetics in patients
- often skipped
How many patients are involved in a Phase1 trial and what does it do?
- 20-100
- checks safety and establishes dose range
- usually tested on healthy patients
What do phase 2 trials do?
- Assess efficacy and side effects
- Not presumed to have therapeutic effects
- 100-300
What do phase 3 trials do?
- tests against current gold standard
- 300-3000
- multicentre randomised control trial
What does phase 4 do?
Post-marketing surveillance
