Characteristics of ongoing studies [ordered by study ID]

Aleris Helse Study
Trial name or title	A randomized study comparing ranibizumab to sham in patients with macular edema secondary to CRVO
Methods	Double-masked randomized controlled trial (phase III)
Participants	Male and female patients aged 50 years and older with both ischemic and non-ischemic CRVO and VA reduction to between 6 ETDRS letters (at 1 m) and 73 letters (at 4 m) inclusive in the study eye, for ≤ 6 months with OCT-confirmed ME
Interventions	0.5 mg ranibizumab versus sham intravitreal injection given monthly for 3 months followed by reinjection if ME for a total of 6 months
Outcomes	Primary: mean change from baseline in BCVA score at 6 months
	Secondary: mean change from baseline in CRT and score on the NEI VFQ-25 near activities subscale
Starting date	March 2007
Contact information	Bettina Kinge, Bettina.Kinge@retinaklinikken.no
Notes	Completed. Results in press but not yet available
BRAVO Study
Trial name or title	Efficacy and Safety of Lucentis for Clinically Significant Macular Edema Secondary to Central Retinal Vein Occlusion (BRAVO)
Methods	Randomized, open label, controlled, two-center phase II study
Participants	Male and female patients aged over 18 years with CRVO and ME persisting for more than 3 months despite conventional medication, with BCVA less than 64 ETDRS letters in the study eye. Patients treated previously with IVTA or macular grid laser excluded.
Interventions	Intravitreal ranibizumab injection monthly for 3 months, with further injection if VA reduces by more than 5 letters at any of the monthly follow-up visits, versus patients treated on an ’as needed’ basis with argon laser PRP or macular grid laser
Outcomes	Primary: mean change in BCVA (ETDRS chart) from baseline to 12 months
	Secondary: change in CRT on OCT
Starting date	August 2009
Contact information	Zsolt Balla, University of Pecs, Dept of Ophthalmology, Hungary. balla07@freemail.hu
Notes	Currently recruiting patients (ClinicalTrial.Gov last checked on 18 June 2010)
Maturi, R.K.
Trial name or title	Single site, masked, randomized, controlled study to assess efficacy of Osurdex as adjunct to Avastin compared with Avastin alone in the treatment of patients with macular edema secondary to central or branch retinal vein occlusion
Methods	Masked, randomized, controlled phase IV study
Participants	Male and female adults aged 18 years and over with BRVO or CRVO of less than one year duration with ME > 250 microns on OCT and VA greater than 24 letters and less than 80 letters in the study eye
Interventions	Baseline 1.25mg bevacizumab intravitreal injection in both groups, with sham implant versus Osurdex 0.7 mg implant. Re-treatment with bevacizumab 1.25 mg as required for persisting ME in both groups
Outcomes	Primary: visual acuity at 6 months
	Secondary: number of injections needed over 6 months
Starting date	March 2010
Contact information	Laura Bleau, eyeresearch2000@yahoo.com
Notes	Currently recruiting patients (ClinicalTrial.Gov last checked on 18 June 2010)
Regeneron Study
Trial name or title	Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (Regeneron 2010)
Methods	Randomized, double-masked, controlled phase III study
Participants	Male and female patients aged 18 years and older with center-involved ME secondary to CRVO with mean CRT ≥ 250 microns on OCT, and ETDRS VA of 20/40 to 20/320 (73 to 24 letters) in the study eye
Interventions	Monthly intravitreal injection of VEGF Trap-Eye 2.0 mg versus sham injection until week 24
Outcomes	Primary: improvement in VA versus baseline after 24 weeks
	Secondary: CRT on OCT at 24 weeks
Starting date	July 2009
Contact information	Robert Vitti, Regeneron Pharmaceuticals
Notes	Currently recruiting patients (ClinicalTrial.Gov last checked on 18 June 2010)
St Erik Eye Study
Trial name or title	Bevacizumab for Central Retinal Vein Occlusion Study (St. Eriks Eye Hospital 2009)
Methods	Phase III randomized, double-masked, controlled clinical trial
Participants	Male and female patients with CRVO duration less than 6 months and BCVA 20/800 to 20/50
Interventions	1.25 mg bevacizumab versus sham intravitreal injection
Outcomes	Primary: the proportion of patients gaining 15 ETDRS letters or more at 6 months
	Secondary: change in CRT and cases of neovascular glaucoma at 6 months
Starting date	May 2009
Contact information	David Epstein, david.epstein@sankterik.se
Notes	Currently recruiting patients (ClinicalTrial.Gov last checked on 18 June 2010)

BCVA: best-corrected visual acuity

BRVO: branch retinal vein occlusion

CRT: central retinal thickness

CRVO: central retinal vein occlusion

ETDRS: Early Treatment Diabetic Retinopathy Study

IVTA: intravitreal triamcinolone

μm: micrometers

m: meter

ME: macular edema

mg: milligram

NEI-VFQ: National Eye Institute Visual Functioning Questionnaire

OCT: ocular coherence tomography

PRP: pan-retinal photocoagulation

VA: visual acuity

VEGF: vascular endothelial growth factor