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trials Flashcards

1
Q

GENEVA

A

BRVO/CRVO: Ozurdex > sham (2mo)
0.35mg = 0.7mg, high IOP with dexamethasone

efficacy and safety of the dexamethasone intravitreal implant (OZURDEX) vs sham injections in eyes with vision loss due to macular edema associated with either a branch retinal vein occlusion (BRVO) or a central retinal vein occlusion (CRVO).

At 6-months follow-up, the percentage of eyes with a > or =15-letter improvement in visual acuity was significantly higher in the dexamethasone intravitreal implant group compared with sham. The percentage of eyes with a > or =15-letter loss in visual acuity was significantly lower in the dexamethasone intravitreal implant group compared with sham at all follow-up visits. The percentage of dexamethasone intravitreal implant group-treated eyes with intraocular pressure of > or =25 mmHg peaked at 16% at day 60 and was not different from sham by day 180.

There was no significant between-group difference in the occurrence of cataract or cataract surgery at 6-months follow-up. The researchers concluded that dexamethasone intravitreal implants can both reduce the risk of vision loss and improve the speed and incidence of visual improvement in eyes with macular edema secondary to BRVO or CRVO.

study established OZURDEX as a safe and effective treatment for macular edema secondary to a BRVO or CRVO.

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2
Q

MARINA trial

A

The MARINA trial looked at the effect of ranibizumab on minimally classic / occult CNV lesions (“M” for minimally).

MARINA (minimally classic/occult trial of the anti-VEGF antibody ranibizumab in the treatment of neovascular AMD)

trial which randomized patients with minimally classic or occult lesions to placebo or monthly ranibizumab injections (0.3 mg and 0.5 mg doses) for 2 years. At 1 year, ~95% of both ranibizumab groups lost fewer than 15-letters as compared to 62.2% of patients receiving sham injections. Also, visual acuity improved by 15 or more letters in 24.8%, 33.8%, and 5.0% in the 0.3 mg, 0.5 mg, and placebo groups respectively. These benefits of ranibizumab were maintained at the 2-year endpoint.

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3
Q

ANCHOR trial

A

Mnemonic: (an anchor looks like a “C” for classic)
The ANCHOR trial studied the effect of ranibizumab on predominantly classic CNV (vs PDT)

Result: Ranibizumab better than PDT for these patients.

ANCHOR: classic, (vs PDT)

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4
Q

BRAVO/CRUISE study

A

BRVO/CRVO: Lucentis x 6mo then PRN > sham x 6mo then PRN (6 mo)

CRUISE = CRVO =
IV ranibizumab dosing (0.3 and 0.5) vs. sham on CRVO macular edema. qmonth x 6. Then 6 mo “observation period” during which all participants could receive additional injections according to a pre-specified reinjection protocol.

Result: Ranibizumab better (both doses)

BRAVO/BRVO =
branch of CRUISE study on BRVO associated edema. Found same results as CRUISE study.

Result: Ranibizumab better than sham

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5
Q

SCORE trial (Standard Care vs. Corticosteroid for Retinal Vein Occlusion)

A

IV triamcinolone ( 1-mg and 4-mg) vs observation in the treatment of PERFUSED CRVO-associated macular edema vision loss.

RESULTS: IV triamcinolone better

benchmark: visual gain of three or more lines. effect lasted up to 2 years

4 mg dose = highest rates of cataract formation, cataract surgery, and elevated pressure within the eye, indicating that the 1 milligram dose is safer

SCORE
BRVO: grid > IVt triamcinolone x2 (36mo)
CRVO: IVt triamcinolone x2 > sham (24mo)
1mg = 4mg in efficacy, but 1mg safer

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5
Q

Silicone oil study

A

Sulfur hexafluoride (SF6) is inferior to either C3F8 or silicone oil in reattachment rates of complex retinal detachments.

C3F8 = silicone oil in proportion of eyes achieving better than 5/200 vision

However, final VA outcomes were slightly better in the silicone oil group overall.

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6
Q

SCORE CRVO trial (Standard Care vs. Corticosteroid for Retinal Vein Occlusion)

A

IV triamcinolone ( 1-mg and 4-mg) vs observation in the treatment of PERFUSED CRVO-associated macular edema vision loss.

RESULTS: IV triamcinolone better

benchmark: visual gain of three or more lines. effect lasted up to 2 years

4 mg dose = highest rates of cataract formation, cataract surgery, and elevated pressure within the eye, indicating that the 1 milligram dose is safer

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8
Q

BVOS (Branch Retinal Vein Occlusion Study)

A

BVOS
Grid laser improves VA if VA3mo
PRP reduced risk of NV + VH, but PRP only if NV

  • grid laser was helpful in increasing the chances of 20/40 vision and a gain in >= 2 lines of vision for patients with chronic (>3 months) macular edema caused by a BRVO.
  • benefit was only seen in patients with intact macular perfusion. In cases of macular non-perfusion, no treatment is indicated.

For macular edema caused by a BRVO, the BVOS recommended waiting for 3 months to allow for spontaneous resolution of edema and blood. Eyes with macular edema are then treated with grid laser if visual acuity is 20/40 or worse. In addition, a fluorescein angiogram (FA) must demonstrate the ABSENCE of macular non-perfusion. If macular non-perfusion is present on FA, then laser should not be undertaken.

Editor’s note: of course with the results of the BRAVO/CRUISE studies, use of anti-VEGF medications like ranibizumab is now the most popular way of treating macular edema associated with branch and central vein occlusions.

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8
Q

BVOS (Branch Retinal Vein Occlusion Study)

A

For macular edema caused by a BRVO, best to wait for 3 months to allow for spontaneous resolution of edema and blood.

Macular edema eyes then treated with grid laser if VA< 20/40 ONLY IN PERFUSED macula (do by FA).

If macular non-perfusion ( >= 5 DAs of non-perfusion) is present on FA, then laser should not be undertaken. Observe q4mo for NVE

Editor’s note: of course with the results of the BRAVO/CRUISE studies, use of anti-VEGF medications like ranibizumab is now the most popular way of treating macular edema associated with branch and central vein occlusions.

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9
Q

BVOS

A

For macular edema caused by a BRVO, the BVOS (Branch Retinal Vein Occlusion Study) recommended waiting for 3 months to allow for spontaneous resolution of edema and blood. Eyes with macular edema are then treated with GRID laser if visual acuity is 20/40 or worse. In addition, a fluorescein angiogram (FA) must demonstrate the ABSENCE of macular non-perfusion. If macular non-perfusion is present on FA, then laser should not be undertaken.

Also, PRP applied when NVI/NVE/NVA occurs, not based on ischemia.

BRVO ischemia = > 5 disc diameters of capillary nonperfusion.

No need to do embolic work-up in BRVO.

Editor’s note: of course with the results of the BRAVO/CRUISE studies, use of anti-VEGF medications like ranibizumab is now the most popular way of treating macular edema associated with branch and central vein occlusions.

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10
Q

CRYO ROP

A

CRYO-ROP study was a multicenter, RCT that compared cryotherapy retinal ablative treatment in the study eye with observation of the fellow eye in 172 subjects with threshold retinopathy of prematurity (ROP).

Threshold disease was defined as five or more contiguous or eight cumulative clock hours of stage 3 ROP in zone 1 or 2 in the presence of “plus” disease. An unfavorable outcome was defined as posterior retinal detachment, retinal fold involving the macula, or retrolental tissue. Unfavorable outcomes were significantly less in the eyes that underwent cryotherapy (21.8%) compared with the untreated eyes (43%).

This study defined threshold ROP and established peripheral retinal ablation as the standard of care in subjects with threshold ROP.

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12
Q

VISION

A

1st pivotal study demonstrating the efficacy of anti-VEGF agents in the Rx of NVAMD

placebo or pegaptanib (i.e. Macugen) at doses of 0.3 mg, 1.0 mg, or 3.0 mg.

Macugen better at all doses and for all lesion types.

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12
Q

VIEW

A

VIEW-1 and 2 studies which demonstrated the noninferiority of aflibercept (i.e. VEGF Trap-Eye) to monthly ranibizumab. Importantly, one study arm demonstrated that the regimen of aflibercept every 2 months (after 3 initial monthly doses) was equivalent to monthly ranibizumab.

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13
Q

CATT (Comparison of AMD Treatments Trial)

A

Basically at 1 year, bevacizumab (i.e. Avastin) = ranibizumab on both a monthly and as-needed basis.

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14
Q

UKPDS

A

The United Kingdom Prospective Diabetes Study (UKPDS) was a multicenter, randomized trial of subjects with type 2 diabetes mellitus that were randomly assigned to receive intensive blood glucose control or conventional blood glucose management. Subjects were also randomly assigned to either receive tight blood pressure control or less tight blood pressure control. Intensive blood glucose control and tight blood pressure control were independently found to both slow the progression and reduce the risk of diabetic retinopathy, neuropathy, and nephropathy. This study established the importance of intensive glucose and blood pressure control in reducing the risk of microvascular complications in type 2 diabetics.

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16
Q

VIP study

A 
PDT > control in occult CNV (w/o classic)
Small area (< 4 disc areas in size, PDT was better

Benchmark: VA less than 15 letters at 2 years.

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17
Q

BEAT ROP

A

compared retinal ablative treatment with IV bevacizumab monotherapy in babies with zone I or zone II posterior stage 3 with plus disease ROP (select high-risk ROP infants).

Conclusion: IV bevacizumab monotherapy, is better than conventional laser therapy, in infants with stage 3+ ROP with zone I but not zone II disease.

18
Q

The Diabetes Control and Complications Trial (DCCT)

A

Intensive > conventional glycemic control in DM1 pts, reduces onset & progression of DR & macular edema

====
Intensive control reduced the risk of developing retinopathy by 76% and slowed the progression of retinopathy by 54%. The risk of neuropathy was reduced by 60% and the risk of nephropathy was reduced by 54% with intensive glucose control.

Established the importance of intensive glucose control in reducing the risk of microvascular complications in type 1 diabetics.

19
Q

CVOS (Central Retinal Vein Occlusion Study)

A

CVOS
Grid laser reduced CME but not VA
PRP not reduced risk of NV, PRP only if NV (>2 clock hrs NVI or any NVA)

PRP is only recommended for ISCHEMIC CRVO when NVI/NVA first occurs.

Two main subtypes of CRVO: non-ischemic and ischemic. ischemic form =>= 10 disc areas of capillary non-perfusion on FA (posterior pole view).

CVOS: prophylatic PRP for ischemic CRVO did not completely prevent the development of iris or angle neovascularization and that future PRP was less effective. Specifically, 20% with ischemic CRVO still developed iris/angle neovascularization.

CVOS: macular grid laser did not significantly improve VA in CVO patients with macular edema in OLDER patients. However, there was a trend toward improved outcomes for younger patients but not statistically significant.

Note: of course now, with BRAVO/CRUISE studies, use of anti-VEGF medications = most popular way of treating macular edema associated with branch and central vein occlusions.

20
Q

TAP trial

A

Mnemonic: tap is a classic form of dance!
tap- CLASSIC CNV

TAP
PDT > control in classic CNV

TAP trial examined the effect of PDT for patients with subfoveal CNV with any classic component. It did not enroll patients with occult CNV with no classic features.

Results: TAP trial showed the greatest benefit of PDT for those patients with predominantly-classic CNV.

21
Q

Endophthalmitis Vitrectomy Study (EVS)

A

Early PPV if LP
8% developed RD

70% (majority) of the organisms isolated were Staphylococcus epidermidis.

22
Q

Early Treatment for Retinopathy of Prematurity (ETROP) study

A

ETROP: early retinal ablative treatment in the study eye vs. conventional management of the fellow eye in 317 subjects with high-risk PRETHRESHOLD retinopathy of prematurity (ROP).

Results: early treatment of high-risk prethreshold ROP =new standard of care. Do retinal ablative therapy for eyes with type I ROP.
Type I ROP definition:
zone I, any stage ROP with plus disease
zone I, stage 3 ROP without plus disease
zone II, stage 2 or 3 with plus disease.

"wait and watch" approach to type II ROP
zone I, stage 1 and 2 without plus disease
zone II, stage 3 without plus disease
===
Benchmark: Grating VA outcomes
==
Conclusion: Early > conventional therapy of prethreshold
disease in reducing VA loss
• Type I ROP = treat (early - <48hrs)
– Zone I, any stage, plus disease
– Zone I, stage 3, no plus disease
– Zone II, stage 2-3, plus disease
• Type II ROP = watch (serial exams)
– Zone I, stage 1 or 2, no plus disease
– Zone II, stage 3, no plus disease
23
Q

RESTORE

A

One of 3 choices: IV ranibizumab monotherapy, combined IV ranibizumab and focal/grid laser, or focal/grid laser monotherapy for DME.

Results: ranibizumab anything better than focal/grid laser alone for DME pts.

Benchmark:

  • mean average change in letter score from baseline through month 12.
  • mean central retinal thickness
24
Q

COMS (Collaborative Ocular Melanoma Study) Large Choroidal Melanoma Trial

A

Divided into 2 RCT for large and medium choroidal melanomas and 1 observational study for small choroidal melanomas.

Large tumor study: compared enucleation alone vs. enucleation pre-treated with external beam radiotherapy. The study found no difference in mortality between these two groups.

Adjunctive radiotherapy did not improve overall survival.

25
Q

COMS (Collaborative Ocular Melanoma Study) Large Choroidal Melanoma Trial

A

Divided into 2 RCT for large and medium choroidal melanomas and 1 observational study for small choroidal melanomas.
Large tumor study: compared enucleation alone vs. enucleation pre-treated with external beam radiotherapy. The study found no difference in mortality between these two groups.
Adjunctive radiotherapy did not improve overall survival

COMS = 3 parts
Large > 10 mm or > 16 mm
don’t irradiate = just enucleate

26
Q

pneumatic retinopexy trial

A

pneumatic retinopexy provided slightly better VA outcome than scleral bucke in patients with mac-OFF RRD <14 day duration

Only patients with causative break in SUPERIOR 2/3 of retina included in the study.
visual outcome not affected in pts who underwent unsuccesful pneumatic retinopexy and then a succesful SB.

27
Q

Early Treatment Diabetic Retinopathy Study (ETDRS)

A

Early PRP (for severe NPDR)
Small improvement in risk of severe VA loss (<5/200) x 4 mo
Most effective in DM2 patients
Focal laser (for CSME)
50% reduction of mod VA loss in CSME over 3 yrs (15% vs 30%)
Increased chance for visual GAIN
Reduced retinal thickening
ASA
650mg/day did not affect rate of retinopathy or vision loss

evaluated:

1) the effects of aspirin (vs. placebo) on diabetic retinopathy
2) focal vs observation in CSME
3) early scatter photocoagulation effective for earlier stages of diabetic retinopathy?

Result: Focal laser should be applied to pts with CSME even if VA 20/20. But not mandated, and patients can be observed closely, esp if most of edema in FAZ.

CSME made by clinical exam (stereo CL biomicroscopy or stereo photography)

Aspirin = no effect on: VH, PDR progression, VA

27
Q

SCORE BRVO

A

efficacy/safety of 1-mg and 4-mg doses of IV triamcinolone vs standard care for eyes with vision loss associated with macular edema secondary to branch retinal vein occlusion (BRVO)

Standard care for BRVO assoc/macular edema was:

(1) grid photocoagulation in eyes without dense macular hemorrhage
(2) deferral of photocoagulation until hemorrhage clears in eyes with dense macular hemorrhage

The researchers recommended that grid photocoagulation remain the standard of care and the benchmark against which other treatments are compared in future clinical trials.

28
Q

MPS subfoveal trials of CNV assoc/w/AMD

A

compared 1 laser wavelength to another when treating CNV

 Extrafoveal & Juxtafoveal MPS:
 laser all (AMD, POHS, idiopathic)

Subfoveal: (only AMD studied)
3.5DD, don’t laser

Laser only classic, not occult

Argon = krypton (no difference)

Wavelength doesn’t affect incidence of recurrence
Duration of treatment should be relatively long to create an intense lesion WITHOUT sudden breaking through of Bruchs’ membrane
However, duration has not been shown to affect rate of recurrence.

BUT: failing to cover the ENTIRE lesion or to achieve a white intensity at least as great as the minimal intensity standards published by the MPS = factors that independently increased likelihood of developing persistent CNV.

29
Q

STOP-ROP

A

• Supplemental O2 at O2Sat 96-99% did not cause progression of prethreshold ROP or reduce surgery

30
Q

LIGHT-ROP

A

• Exposure to ambient light does not affect

incidence/severity of ROP

31
Q

Age-Related Eye Disease Study (AREDS) - original

A

Micronutrients to prevent AMD

intermediate AMD (defined as extensive intermediate drusen, one large drusen, or nonsubfoveal geographic atrophy) in one or both eyes benefited from treatment with a reduction in progression to advanced AMD.

Drusen size: small (< 64 microns) to intermediate (64-124 microns) to large (>124 microns).

32
Q

Diabetic Retinopathy Clinical Research network (DRCR.net) protocol

A

(1) sham injection + prompt laser
(2) ranibizumab 0.5 mg + prompt laser
(3) ranibizumab 0.5 mg + delayed laser
(4) triamcinolone 4 mg + prompt laser.

best VA = primary endpoint (i.e. at 52 weeks)

ranibizumab + laser groups did better than the previous gold standard of macular laser alone.

BUT, Pseudophakic patients gained equivalent vision in the ranibizumab/laser groups as the triamcinolone/laser group (but higher incidence of glaucoma).

amount of initial edema did not alter the overall result. vision gain was similar whether leakage was focal or diffuse

Only center-involving edema

34
Q

Diabetic Retinopathy Study (DRS)

A

Argon/Xenon laser for?
severe NPDR OU
high-risk PDR in one eye

Defined high-risk PDR
PRP for high-risk PDR: 50% reduction in severe VA loss x 5 yrs

PRP or no laser for bilateral severe NPDR & PDR
PRP reduced the risk of severe visual loss by 50% or more in subjects with high-risk PDR.

High-risk PDR definition:

(1) NVE + VH
(2) NVD >= 1/4 to 1/3 disc area
(3) NVD not meeting #2 criteria with VH

Scatter photocoagulation 1200 burn with 500 micron spot size approximately 1/2 to 1 spot size apart with 0. 1 sec duration

====
Main endpoint was “severe vision loss”: VA< 5/200 for at least 4 months.

34
Q

According to the Wisconsin Epidemiologic Study of Diabetic Retinopathy (WESDR), which of the following groups of patients had the highest risk of blindness from diabetic retinopathy?

A

3.6% of type 1 diabetic patients were legally blind after 20 years with 86% of the blindness being caused by diabetic retinopathy.
In contrast, 1.6% of type 2 diabetic patients were legally blind after 20 years with only 1/3 of the blindness being caused by diabetic retinopathy.

northern European descent

35
Q

DRVS

A

clearly showed a benefit of early vitrectomy for type 1 diabetics with severe vision loss from a severe VH.

Early (1 yr) PPV for non-clearing VH
Early PPV improved VA outcome in DM1, not DM2 patients

Indications for PPV
Dense non-clearing VH
TRD threatening macula
Combined TRD/RRD
Diffuse DME w/ traction
Recurrent VH despite max PRP

early vitrectomy increased the chance of 20/40 vision but no clear benefit in type 2 diabetics.

Though the DRVS provided valuable data, most vitreoretinal surgeons will perform early surgery also for type 2 diabetics with severe VH given the improvement in vitreoretinal surgical techniques, especially the routine use of concomitant endolaser during the procedure.

36
Q

COMS - medium or small

A

Medium 2.5 -10 mm ht, 16 mm diameter
usually plaque

Small: 1-3 mm in apical height, 5 mm in basal diameter, 5 yr all cause mortality 6% = good to know

plaque radioptheray most common
plaque is 3 mm in diameter larger than the measured lesion.

37
Q

United Kingdom Prospective Diabetes Study (UKPDS)

A

Intensive > conventional glycemic control in DM2 pts, reduces onset & progression of DR
Intensive BP control slowed progression of DR
No difference bet. ACEi & BB

study established the importance of intensive glucose and blood pressure control in reducing the risk of microvascular complications in type 2 diabetics.

38
Q

AREDS2

A

No effect on advanced AMD incidence with the elimination of beta carotene and/or the lowering of zinc doses from the AREDS formulation. Higher incidence of lung CA in pts taking formulations containing beta-carotene.

AREDS2: can substitute beta-carotene with lutein + zeaxanthin.

39
Q

ESCRS (European Society of Cataract and Refractive Surgeons) trial

A

prospective trial evaluating intracameral injection of cefuroxime after cataract surgery
reduction in rates of endophthalmitis was 5x

Mnemonic: think ESCRS has 5 letters, reduced risk was 5x.

40
Q

COPERNICUS

A

CRVO: IVt Eylea 2mg qmo > sham (6 mo)

Retina (11 decks)

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