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Clinical Trials in Ophthalmology

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

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  1. Clinical Trials in Ophthalmology Mohamed Soliman PGY-2 Ophthalmology LSUHSC Shreveport

  2. Diabetic Retinopathy

  3. 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

  4. 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 Mild NPDR Moderate NPDR Early PDR

  5. 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

  6. 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

  7. 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

  8. DRSDiabetic Retinopathy Study Study Question • Is Photocoagulation (argon or xenon arc) effective in treating DR Eligibilty • PDR or Severe NPDR Outcome variables • SVL ( VA < 5/200 )

  9. DRSDiabetic Retinopathy Study Results • 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

  10. 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 Results 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

  11. 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) Results • 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

  12. DVSDiabetic Vitrectomy Study Objective • Natural course and effect of surgical intervention on severe PDR Results • 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

  13. AMD and CNV

  14. AREDSAge-Related Eye Disease Study Objective • To evaluate whether antioxidants or zinc supplements can reduce development or progression of AMD Results • Patients with intermediate, dry AMD, or unilateral advanced AMD benefited from antioxidants and zinc supplementation with respect to vision loss and progression of AMD

  15. MPSMacular Photocoagulation Study Objective • 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

  16. MPSMacular Photocoagulation Study Results • 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

  17. The Photodynamic Thearpy (PDT) Era

  18. TAPTreatment of AMD with PDT study Objective • To determine if PDT with verteporfin can reduce visual loss in patients with subfoveal CNV Results • Patients treated with PDT+Verteporfin sustained less MVL. This was mainly in seen in predominantly classic CNV (>50% of area is classic).

  19. VIPVerteporfin in PDT Trial (AMD and Myopia) Objective • To determine if PDT + Verteporfin can reduce visual loss in Patients with subfoveal CNV Results • Decreased MVL and SVL • Note : PDT use has dropped significantly with the advent of pharmacotherapy, it may be used in combination with antiangiogenisis treatments.

  20. The Anti-VEGF Era

  21. VISIONVEGF inhibition Study in Ocular Neovascularization Objective • To determine if pegaptanib (Macugen) can reduce the risk of visual loss in subfoveal CNVs Results • 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

  22. ANCHORAnti-VEGF for the tretment of Predominantly Classic CNV in AMD Objective • 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 Results • 95% of patients given Lucentis maintained or improved their vision after 12 months • 64% treated with PDT+ Verteporfin over 12 months

  23. MARINAMinimally classic/Occult Trial of Ranibizumab in Neovascular AMD Objective • 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 Results • 95% of patients experienced visual improvement or stabilization after 12 months

  24. Post-operative Endophthalmitis

  25. EVSEndophthalmitisVitrectomy Study Objective • Evaluate the role of PPV and Intravenous antibiotics in post-operativebacterialendophthalmitis Participants • 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

  26. EVSEndophthalmitisVitrectomy Study Results • 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

  27. Vein Occlusions

  28. CVOSCentral Vein Occlusion Study Objective • To determine if grid laser improve VA with CRVO and perfused ME. • To determine if early PRP prevents NVI/NVA Results • 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)

  29. 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)

  30. 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

  31. 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

  32. Retinopathy of PrematurityROP

  33. STOP-ROPSupplemental Therapeutic Oxygen for Prethreshold ROP Objective • To test whether supplemental oxygen would decrease the progression from prethreshold to threshold disease. Results • 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

  34. CROPTrial of Cryotherapy for ROP Objective • To determine if Cryotherapy to the peripheral avascular retina in severe ROP prevented cicatricial changes and RD. Results • 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

  35. 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

  36. Herpetic Eye Disease

  37. HEDSHerpetic Eye Disease Study Objective: • To evaluate the efficacy of topical steroids and oral acyclovir in treating HSV stromalkeratitis and iridocyclitisin conjunction with topical trifluridine (Viroptic). Results • Do topical steroids treat stromalkeratitis? Yes. They treat stromal inflammation and shorten the duration of keratitis

  38. 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

  39. Choroidal Melanoma

  40. COMSCollaborative Ocular Melanoma Study COMS large Choroidal Melanoma trial • Large Apex > 10 Base >16 • Compared Enucleation alone to Enucleationpreceeded by External beam RT Results • Established appropriateness of primary enucleation alone (RT did not improve overall survival)

  41. COMSCollaborative Ocular Melanoma Study COMS Medium ChoroidalMelanoma trial • Medium Apex <10Base <16 • Compared Standardized enucleation and brachytherapy (iodine 125) • Results

  42. 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

  43. Audio-Visual tour

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