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UCL Medical Retina 2 > Unit 4 - AMD Clinical trials > Flashcards

Unit 4 - AMD Clinical trials Flashcards

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USMLE® Step 1 flashcards
1
Q

Which trial compared PDT to Lucentis?

A
  • Letters were gained with Lucentis
  • 90% avoided >15 letters of vision
  • 1/3 of eyes gained >15 letters at 2 years
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2
Q

Which study compared Lucentis to Sham in both occult and classic CNVM?

A

Marina, same results as Anchor

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3
Q

Following Anchor and Marina which trial looked at giving two different strengths of Lucentis at a 0,4,8, weeks then 3 monthly

A

Pier, 90% avoided vision loss but eyes did not gain significant vision

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4
Q

Which trial led to the adoption of a prn basis of Lucentis and why?

A

Pronto, showed that after 3 loading doses prn was as effective but with less injections

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5
Q

Which trial showed that Lucentis produced more GA that Avastin?

A

CATT, compared Lucentis prn or monthly to Avastin prn or monthly.

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6
Q

Which trial compared Eylea to Lucentis?

A

View 1 and 2

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7
Q

Which trial compared anti-VEGF to PDT for Myopic CNVM

A

Radiance

Showed a 10 letter increase compared to just 2 letters with PDT

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8
Q

Which trial compared anti-VEGF to sham treatment for myopic CVNM?

A

up 13 letters versus 4 with just 2 injections

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9
Q

What did Bolt compare?

A

Avastin to macula laser for DMO

Bolt (avastin to laser)

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10
Q

Which trial compared ozurdex to a sham injection for DMO?

A

MEAD, average number of implants was just 4 over 3 years but more cataracts.

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11
Q

Which trial compared illuvien in two concentrations to sham for DMO?

A

Fame! Illuvien worked and maintained va for 3years BUT incidence of cataracts and high IOPs was higher.

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12
Q

Which trial compared lucentis with lucentis + laser and sham injection+ lase for DMO?

A

RESTORE, lucentis with or without laser resulted I. 40% gaining 10 letters and 23% more than 15 letters.

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13
Q

What did the drcr .net trial look at?

A

lucentis + prompt or delayed laser versus illuvien + prompt or delayed laser

  • lucentis gained most letters
  • prompt laser plus lucentis resulted in fewer injections
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14
Q

Which trial compared two strengths of lucentis versus sham injection?

A
  1. Rise and ride
  2. 42% gained more than 15 letters + general improvement in DR.
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15
Q

What did vivid and vista look at?

A

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.

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16
Q

What current treatments are being looked at for wet amd?

A

Harrier, brolucizumab, currently in phase 3 against Eylea

Sequoia and Cedar, phase 3 looking at DARPins, being compared against lucentis 4 weekly.

17
Q

What drug is being investigated to treat RPE65 retinal dystrophy?

A

luxturna 425k dollars per eye

18
Q

What did the Mahalo trial look at?

A

Lampalizumab, for ga - failed to deliver.

19
Q

What is the macustar treatment looking at?

A

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.

20
Q

What is phase 0?

A
  1. Investgates pharmacokinetics in patients
  2. often skipped
21
Q

How many patients are involved in a Phase1 trial and what does it do?

A
  1. 20-100
  2. checks safety and establishes dose range
  3. usually tested on healthy patients
22
Q

What do phase 2 trials do?

A
  1. Assess efficacy and side effects
  2. Not presumed to have therapeutic effects
  3. 100-300
23
Q

What do phase 3 trials do?

A
  • tests against current gold standard
  • 300-3000
  • multicentre randomised control trial
24
Q

What does phase 4 do?

A

Post-marketing surveillance

25
Q

What is the risk reduction of developing wet amd if you use areds vitamins?

A

25%

26
Q

What did cruise and horizon investigate?

A

efficacy of lucentis in CRVO

27
Q

What did Galileo and Copernicus investigate?

A

efficacy of Eylea in crvo

28
Q

Wha did bravo, horizon and retain investigate?

A

efficacy of lucentis versus not treating in BRVO

29
Q

What did the hastens study look at?

A

the efficacy of anti-VEGF in macro-aneurysms

30
Q

Which study led to the approval of Lucentis treatment for DMO in the US?

A

Rise and Ride

UCL Medical Retina 2 (30 decks)

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