Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO) (GALILEO)

To determine the efficacy of vascular endothelial growth factor (VEGF) Trap-Eye injected into the eye on vision function in subjects with macular edema as a consequence of central retinal vein occlusion.

Official Title

A Randomized, Double-masked, Sham-controlled Phase 3 Study of the Efficacy, Safety and Tolerability of Repeated Intravitreal Administration of VEGF Trap-Eye in Subjects With Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)

Conditions

Retinal Vein Occlusion

Study Type

Interventional

Study Design

Randomized, Parallel Assignment,  Double Blind (Subject, Investigator, Outcomes Assessor), Treatment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• The proportion of subjects who gain at least 15 letters in BCVA on the EDTRS chart compared with baseline at the Week 24 endpoint
  [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

• Change from baseline in BCVA score
  [ Time Frame: week 24 ] [ Designated as safety issue: No ]
• Absolute change from baseline in central retinal thickness, assessed by OCT
  [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
• Proportion of subjects progressing to anterior segment neovascularization, neovascularization of the optic disc (NVD), or neovascularization of the retina elsewhere (NVE) requiring pan-retinal photocoagulation
  [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
• Change in the NEI-VFQ-25 total score from baseline
  [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
• Change in the EQ-5D score from baseline
  [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

 

Arms
Arm 1: Experimental	Drug: VEGF Trap-Eye (BAY86-5321)  Intravitreal injection. Weeks 0 to 20 injection of VEGF  Trap-Eye every 4 weeks; weeks 24 to 48 every 4 weeks re- assessment and either (PRN) injection of VEGF Trap-Eye or sham injection;weeks 52 to 100 safety follow-up.
Arm 2: Sham Comparator	Other: Sham treatment Sham treatment. Weeks 0 to 20 sham treatment every 4 weeks; weeks 24 to 48 every 4 weeks re-assessment and sham injection; weeks 52 to 100 safety follow-up.

Study Start

October 2009 – August 2012

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and older
• Genders Eligible for Study: Both
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Center-involved macular edema secondary to central retinal vein occlusion (CRVO) for no longer than 9 months with mean central subfield thickness >= 250 µm on optical coherence tomography (OCT).
• Adults >= 18 years.
• Early treatment diabetic retinopathy study (ETDRS) best corrected visual acuity (BCVA) of 20/40 to 20/320 (73 to 24 letters) in the study eye.

Exclusion Criteria:

• Previous treatment with anti-angiogenic drugs in the study eye (Pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc.)
• Prior panretinal laser photocoagulation or macular laser photocoagulation in the study eye
• CRVO disease duration > 9 months from date of diagnosis
• Previous use of intraocular corticosteroids in the study eye or use of periocular corticosteroids in the study eye within the 3 months prior to Day 1
• Iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in either the study eye or fellow eye

Total Enrolment

165

Contact Details

Bayer Clinical Trials Contact
clinical-trials-contact@bayerhealthcare.com

 

Australia, New South Wales

Chatswood 2067

Sydney 2000

Westmead 2145

Parramatta 2150

Australia, Victoria

East Melbourne 3002

Australia, Western Australia

Nedlands 6009