13 Clinical Trials Summary
13.0 Introduction
13.1 Cornea
13.2 Cataract
13.3 Medical Retina – Age-Related Macular Degeneration (AMD)
13.4 Medical Retina - Diabetes
13.5 Medical Retina – Retinal Vein Occlusion (RVO)
13.6 Vitreoretinal Surgery
13.7 Glaucoma
13.8 Oculoplastics
13.9 Paediatrics
13.10 Neuro-Ophthalmology
13.11 Ocular Oncology
13.5 Medical Retina – Retinal Vein Occlusion (RVO)
IVB = Bevacizumab, IVR = Ranibizumab, IVA = Aflibercept, IVTA = Triamcinolone
BVOS [lv,lvi]
Laser for BRVO macular oedema
For BRVO > 3 months duration, VA 6/12 or worse, no macular haemorrhage:
Macular grid laser = 2x chance of VA gain of 2 lines
Sectoral PRP for NV reduces risk of VH
1984. Argon laser photocoagulation for macular edema in branch vein occlusion. The Branch Vein Occlusion Study Group. Am J Ophthalmol 98(3) 271-282.
Rosenberg, N.R. 1986. Argon Laser Scatter Photocoagulation for Prevention of Neovascularization and Vitreous Hemorrhage in Branch Vein Occlusion: A Randomized Clinical Trial. Archives of ophthalmology (1960) 104(1) 34-41.
CVOS [lvii,lviii]
Laser for CRVO macular oedema
Macular laser not beneficial for macular oedema
PRP for NV only once it develops
If ischaemic CRVO - monthly F/U
1995. Evaluation of grid pattern photocoagulation for macular edema in central vein occlusion. The Central Vein Occlusion Study Group M report. Ophthalmology 102(10) 1425-1433.
1995. A randomized clinical trial of early panretinal photocoagulation for ischemic central vein occlusion. The Central Vein Occlusion Study Group N report. Ophthalmology 102(10) 1434-1444.
SCORE [lix,lx]
IVT for BRVO/CRVO macular oedema
IVTA no different to macular grid laser for BRVO macular oedema (but 4mg IVTA had greater IOP rise and cataract)
IVTA superior to observation for CRVO (1mg better than 4mg in terms of safety)
Group*, T.S.S.R. 2009. A Randomized Trial Comparing the Efficacy and Safety of Intravitreal Triamcinolone With Standard Care to Treat Vision Loss Associated With Macular Edema Secondary to Branch Retinal Vein Occlusion: The Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) Study Report 6. Archives of Ophthalmology 127(9) 1115-1128.
Ip, M.S., Scott, I.U., Vanveldhuisen, P.C. et al. 2009. A Randomized Trial Comparing the Efficacy and Safety of Intravitreal Triamcinolone With Observation to Treat Vision Loss Associated With Macular Edema Secondary to Central Retinal Vein Occlusion: The Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) Study Report 5. Archives of ophthalmology (1960) 127(9) 1101-1114.
BRAVO [lxi]
BRVO macular oedema
IVR effective (improved 3 lines vs. improved 1.5 lines sham)
Brown, D.M., Campochiaro, P.A., Bhisitkul, R.B. et al. 2011. Sustained Benefits from Ranibizumab for Macular Edema Following Branch Retinal Vein Occlusion: 12-Month Outcomes of a Phase III Study. Ophthalmology 118(8) 1594-1602.
CRUISE [lxii]
Non-ischaemic CRVO macular oedema
IVR effective (improved 3 lines vs. improved 0 lines sham)
Brown, D.M., Campochiaro, P.A., Singh, R.P. et al. 2010. Ranibizumab for Macular Edema following Central Retinal Vein Occlusion: Six-Month Primary End Point Results of a Phase III Study. Ophthalmology 117(6) 1124-1133.e1121.
OZURDEX GENEVA STUDY [lxiii,lxiv]
BRVO/CRVO macular oedema
Ozurdex effective (reduced vision loss, improved speed and incidence of visual improvement) compared with sham at 6 months
Haller, J.A., Bandello, F., Belfort, R. et al. 2010. Randomized, Sham-Controlled Trial of Dexamethasone Intravitreal Implant in Patients with Macular Edema Due to Retinal Vein Occlusion. Ophthalmology 117(6) 1134-1146.e1133.
Haller, J.A., Bandello, F., Belfort, R. et al. 2011. Dexamethasone Intravitreal Implant in Patients with Macular Edema Related to Branch or Central Retinal Vein Occlusion: Twelve-Month Study Results. Ophthalmology 118(12) 2453-2460.
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13.4 Medical Retina - Diabetes
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Vitreoretinal Surgery Online
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