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Clinical Trials in Ophthalmology. Mohamed Soliman PGY-2 Ophthalmology LSUHSC Shreveport. Diabetic Retinopathy. ET DRS Early treatment Diabetic Retinopathy Study. Study Questions Effectiveness of Photocoagulation DR and DME Effectiveness of Asprin in preventing progresion of DR

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clinical trials in ophthalmology

Clinical Trials in Ophthalmology

Mohamed Soliman

PGY-2 Ophthalmology

LSUHSC Shreveport

et drs early treatment diabetic retinopathy study
ET DRSEarly treatment Diabetic Retinopathy Study

Study Questions

  • Effectiveness of Photocoagulation DR and DME
  • Effectiveness of Asprin in preventing progresion of DR

Outcome Variables

  • SVL (Severe Visual Loss) : VA < 5/200 for at least 4 months
  • MVL (Moderate Visual Loss) : Doubling of Visual angle
  • Progression of DR
et drs early treatment diabetic retinopathy study1
ET DRSEarly treatment Diabetic Retinopathy Study

Results for Early Scatter Photocoagulation

  • Did not reduce the risk of SVL
  • Not indicated in Mild / Moderate NPDR
  • More effective for Type 2 DM


Moderate NPDR

Early PDR

et drs early treatment diabetic retinopathy study2
ET DRSEarly treatment Diabetic Retinopathy Study

Defined CSME as :

  • Retinal edema within 500 µm of center of macula
  • HE within 500 µm of center of macula if associated with thickening of adjacent retina
  • A zone of thickening larger than 1 DD if located within 1 DD of the center of the macula
et drs early treatment diabetic retinopathy study3
ET DRSEarly treatment Diabetic Retinopathy Study

Results for focal photocoagulation for DME

  • Decreased risk of MVL
  • Increased chance of visual gain

(halving of Visual angle)

  • Decreased retinal thickening
et drs early treatment diabetic retinopathy study4
ET DRSEarly treatment Diabetic Retinopathy Study

Results for Asprin

  • Did not alter progression of DR
  • Did not affect VA
  • Did not increase Vitreous Hemorrhage
  • Did decrease the risk of Cardiovascular Morbidity and mortality
drs diabetic retinopathy study
DRSDiabetic Retinopathy Study

Study Question

  • Is Photocoagulation (argon or xenon arc) effective in treating DR


  • PDR or Severe NPDR

Outcome variables

  • SVL ( VA < 5/200 )
drs diabetic retinopathy study1
DRSDiabetic Retinopathy Study


  • Photocoagulation decreased the risk of SVL
  • Greatest benefit to High Risk PDR

Recommended prompt treatment

of“High Risk PDR”

  • Mild NVD + Vitreous Hemorrhage
  • Moderate NVE + Vitreous Hemorrhage
  • Mod/Severe NVD (1/4 – 1/3 NVD)

with or without Vitreous Hemorrhage

High Risk PDR

3 months after laser

dcct diabetes control and complications trial
DCCTDiabetes Control and Complications Trial

Study question

  • Will intensive control of Blood sugar (BS) in Type 1 DM slow the development of DR or slow its progression


Intensive control of BS

  • Decreased risk of developing DR (76%)
  • Slowed progression of DR (54%)
  • Decreased risk of Neuropathy (60%) Albuminuria (54%)

But …

  • Early worsening of DR in 1st year
  • Increased risk of Hypoglycemic events
ukpds united kingdom prospective diabetes study
UKPDSUnited Kingdom Prospective Diabetes Study

Study Questions

  • Will intensive control of Blood Sugar (BS) in Type 2 DM decrease the microvascular complications of Diabetes
  • Will intensive control of Blood Pressure (BP) in Type 2 DM decrease the microvascular complications of Diabetes (including DR progression)


  • Intensive control of BS slowed the progression of DR and decreased the risk of micro vascular complications
  • Intensive control of BP slowed the micro and macrovacular complications of DM
dvs diabetic vitrectomy study
DVSDiabetic Vitrectomy Study


  • Natural course and effect of surgical intervention on severe PDR


  • Type 1 DM with Dense Vitreous Hemorrhage (VH) and SVL in 1 eye :

Early Surgery (1-6 m after visual loss)

  • Type 2 DM with dense VH:

No difference between early and late vitrectomy

Note: Endolaser was not yet available during this study 1988 and microsurgical techniques have greatly improved so outcomes in PPV may be better than those reported in the DVS

areds age related eye disease study
AREDSAge-Related Eye Disease Study


  • To evaluate whether antioxidants

or zinc supplements can reduce

development or progression of AMD


  • Patients with intermediate, dry AMD, or unilateral advanced AMD benefited from antioxidants and zinc supplementation with respect to vision loss and progression of AMD
mps macular photocoagulation study
MPSMacular Photocoagulation Study


  • Does laser treatment to leaking CNVs prevent significant visual loss compared to observation

Study design

  • Photocoagulation of Extrafoveal, juxtfoveal and subfoveal leaking CNVs

Outcome variables

  • Severe Visual loss (SVL) = loss of 6 or more lines, or quadrupling of the visual angle
mps macular photocoagulation study1
MPSMacular Photocoagulation Study


  • Laser decreased the risk of SVL in eyes with Extrafoveal and JuxtafovealCNV (AMD,POHS and idopathic)compared to no treatment
  • InSubfovealCNVs there was an initial drop in VA but after 1 year resulted in a decrease in SVL compared to observed eyes. Persistent or recurrent CNV was noted in 51% of lasered eyes in 24 months
tap treatment of amd with pdt study
TAPTreatment of AMD with PDT study


  • To determine if PDT with verteporfin

can reduce visual loss in patients with

subfoveal CNV


  • Patients treated with PDT+Verteporfin sustained less MVL. This was mainly in seen in predominantly classic CNV (>50% of area is classic).
vip v erteporfin in pdt trial amd and myopia
VIPVerteporfin in PDT Trial (AMD and Myopia)


  • To determine if PDT + Verteporfin can reduce visual loss in Patients with subfoveal CNV


  • Decreased MVL and SVL
  • Note : PDT use has dropped significantly with the advent of pharmacotherapy, it may be used in combination with antiangiogenisis treatments.
vision vegf inhibition study in ocular neovascularization
VISIONVEGF inhibition Study in Ocular Neovascularization


  • To determine if pegaptanib (Macugen) can reduce the risk of visual loss in subfoveal CNVs


  • 70% of patients lost < 3 lines
  • 6% showed visual gain
  • Endophthalmitis after injection

(1.3 risk/patient/year)

  • Note: Use of this drug has dropped as newer antiangiogenesis agents have been developed
anchor anti vegf for the tretment of predominantly classic cnv in amd
ANCHORAnti-VEGF for the tretment of Predominantly Classic CNV in AMD


  • To determine if monthly intravitrealRanibizumab (Lucentis) can reduce visual loss in patients with predominantly classic CNV 2ry to wet AMD

Study design

  • Patients were given Lucentis every month for 24 months and compared to PDT with verteporfin


  • 95% of patients given Lucentis maintained or improved their vision after 12 months
  • 64% treated with PDT+ Verteporfin over 12 months
marina minimally classic occult trial of ranibizumab in neovascular amd
MARINAMinimally classic/Occult Trial of Ranibizumab in Neovascular AMD


  • To determine if monthly Ranibizumab (Lucentis) can reduce visual loss in Patients with occult Subfoveal CNV 2ry to wet AMD .

Study design

  • Patients were given Lucentis every 4 weeks for 24 months and compared to placebo


  • 95% of patients experienced visual improvement or stabilization after 12 months
evs endophthalmitis vitrectomy study
EVSEndophthalmitisVitrectomy Study


  • Evaluate the role of PPV and Intravenous antibiotics in post-operativebacterialendophthalmitis


  • Patients with bacterial endophthalmitis within 6 weeks of onset of infection

Study design

  • Patients randomized to systemic antibiotics or not, and to immediate PPV or to immediate tap/inject
evs endophthalmitis vitrectomy study1
EVSEndophthalmitisVitrectomy Study


  • Systemic Antibiotics not effective : No difference in VA whether or not systemic antibiotics (Amikacin/Ceftazidime) were employed
  • Tap/inject for better than LP vision : No difference in outcomes between PPV and tap/inject group for VA better than LP
  • Immediate PPV for LP vision: showed much better results

Note : Revolutionized treatment of post-cataract surgery endophthalmitis making it an office procedure of tap and inject for most eyes

cvos central vein occlusion study
CVOSCentral Vein Occlusion Study


  • To determine if grid laser improve VA with CRVO and perfused ME.
  • To determine if early PRP prevents NVI/NVA


  • Grid laser treatment in the macula reduced FA evidence of macular edema, yet yielded no benefit in VA
  • (might be beneficial in younger patients with macular edema)

Most important risk factor for NVI is poor VA and larger areas of retinal capillary nonperfusion

  • PRP should be done after 2 clock hours of NVI
  • Prophylactic PRP does not decrease the incidence of NVI
  • (not done in clinical practice)
bvos branch vein occlusion study
BVOSBranch Vein Occlusion Study
  • Objective
  • Can focal macular laser improve VA in BRVOs with ME and VA ≤ 20/40.
  • Can scatter laser prevent NV and VH in BRVOs.
  • Results
  • Improved VA after laser for ME with intact foveal vasculature and VA ≤ 20/40
bvos branch vein occlusion study1
BVOSBranch Vein Occlusion Study
  • Results
  • PRP to the area of nonperfusioncaused regression of new vessels with retinal or disc neovascularization
  • Ischemia alone is not an indication for scatter laser
  • Patients should be observed for the development of neovascularization
  • Scatter laser reduced the risk of VH in eyes with recent BRVO that developed neovascularization
stop rop supplemental therapeutic oxygen for prethreshold rop
STOP-ROPSupplemental Therapeutic Oxygen for Prethreshold ROP


  • To test whether supplemental oxygen would decrease the progression from prethreshold to threshold disease.


  • Supplemental oxygen did not cause further progression of prethershold ROP but also did not reduce the number of infants requiring ablative therapy
  • Oxygen increased the risk of adverse pulmonary events
crop trial of cryotherapy for rop
CROPTrial of Cryotherapy for ROP


  • To determine if Cryotherapy to the

peripheral avascular retina in severe

ROP prevented cicatricial changes and RD.


  • Cryotherapy to the avascular anterior retina in ROP eyes with thershold disease showed a reduction by half in unfavourable outcomes at 1 year
  • Threshold disease
    • Zone 1 or Zone 2
    • Stage 3 (5 contiguous or 8 total clock hours)
    • With plus disease
  • At 10 years eyes that received Cryotherapy were still much less than control eyes to be blind
et rop early treatment for retinopathy of prematurity study
ET-ROPEarly Treatment for Retinopathy of Prematurity Study
  • Determined that earlier laser therapy can improve visual and anatomic outcomes in ROP
  • Recommended laser therapy for
  • Type 1 Prethreshold disease
    • Zone 1 with plus disease
    • Zone 1 with stage 3
    • Zone 2 , stage 2/3 with plus Disease
  • Implied treating an additional

50% more patients than with CROP guidlines

heds herpetic eye disease study
HEDSHerpetic Eye Disease Study


  • To evaluate the efficacy of topical steroids and oral acyclovir in treating HSV stromalkeratitis and iridocyclitisin conjunction with topical trifluridine (Viroptic).


  • Do topical steroids treat stromalkeratitis?

Yes. They treat stromal inflammation

and shorten the duration of keratitis

heds herpetic eye disease study1
HEDSHerpetic Eye Disease Study

Question and Answer

Is oral acyclovir helpful in:

  • A) treating stromalkeratitis

(in addition to trifluridine and steriods)…………….. No

  • B)treating HSV iritis ……………………………….…..Not sure. Probably
  • C)prevent development of Stromalkeratitis

and iritis in patients with epithelial keratitis…….… No

  • D)prophylaxis against HSV recurrences……………...Yes
coms collaborative ocular melanoma study
COMSCollaborative Ocular Melanoma Study

COMS large Choroidal Melanoma trial

  • Large Apex > 10 Base >16
  • Compared Enucleation alone to

Enucleationpreceeded by External beam RT


  • Established appropriateness of primary enucleation alone (RT did not improve overall survival)
coms collaborative ocular melanoma study1
COMSCollaborative Ocular Melanoma Study

COMS Medium ChoroidalMelanoma trial

  • Medium Apex <10Base <16
  • Compared Standardized enucleation

and brachytherapy (iodine 125)

  • Results
coms collaborative ocular melanoma study2
COMSCollaborative Ocular Melanoma Study

COMS Small ChoroidalMelanoma trial

  • Small Apex 1-2.4 Base 4-8
  • Observational study for small tumors
  • Melanoma specific mortality 1 % at 5 y

Clinical Risk factors:

-Greater initial thinckness

-presence of orange pigment

-absence of Drusen &/or RPE changes