Efficacy and Safety of Lucentis for Clinically Significant Macular Edema Secondary to Central Retinal Vein Occlusion

Macular Edema Clinical Trial

— BRAVO  

Official title:

A Randomized, Controlled, Two-center Phase II Study Assessing the Efficacy and Safety of Intravitreal Lucentis Injections in Patients With Clinically Significant Macular Edema Secondary to Central Retinal Vein Occlusion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01123564
• Other study ID #: CRFB002AHU02T
• Status: Recruiting
• Phase: Phase 2
• First received: May 12, 2010
• Last updated: May 13, 2010
• Start date: August 2009
• Est. completion date: September 2011

Study information

• Verified date: May 2010
• Source: University of Pecs
• Contact: Zsolt Balla, MD
• Phone: +3672536141
• Email: balla07[@]freemail.hu
• Is FDA regulated: No
• Health authority: Hungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial Summary

This study aims to assess if Lucentis injection applied into the eye is superior to conventional treatment concerning the prevention of visual loss in patients having clinically significant macular edema secondary to retinal vein occlusion

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Macular edema persisting for more than 3 months period despite conventional medication.

• Central retinal vein occlusion is confirmed by slit-lamp biomicroscopy and fluorescein angiography (FLAG).

• Patients randomized into ranibizumab-treated group do not receive macular laser treatment.

• Macular edema is defined by OCT: the thickness of central foveal area calculated by macular map analysis is above 280 µm and/or retinal thickness is above 330 µm at any region of the macula calculated by retinal thickness analysis.

• Baseline visual acuity is less than 64 ETDRS letters (or 0.4 decimal equivalent).

Exclusion Criteria:

• Diabetes mellitus

• Additional vitreoretinal diseases

• History of pars plana vitrectomy

• Previous macular grid laser treatment

• Intravitreal triamcinolone acetonid treatment

• Complicated cataract surgery

• Advanced glaucomatous damage of optic nerve head

• Cataract (except mild, defined as grade 1 nuclear sclerosis and/or grade 1 posterior subcapsular cataract)

• Age-related macular degeneration

• Pregnancy and lactation

• Women in childbearing potential who are not using double safe contraception

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Edema
• Macular Edema
• Retinal Vein Occlusion

Intervention

Drug:
• ranibizumab
applied monthly in the first 3 months period, and after this only if visual acuity (VA) decreases with more than 5 letters at any monthly visits

Radiation:
• Argon laser treatment
Conventional grid pattern argon laser treatment and panretinal argon laser photocoagulation in an as needed basis.

Locations

Country	Name	City	State
Hungary	Debrecen Medical and Health Science Center Dept of Ophthalmology	Debrecen
Hungary	University of Pecs, Medical School, Department of Ophthalmology	Pecs

Sponsors (2)

Lead Sponsor	Collaborator
University of Pecs	University of Debrecen

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy compared to conventional treatment assessed by BCVA(best corrected visual acuity)	To assess the superiority of intravitreal (IVT) ranibizumab to conventional treatment concerning prevention of visual loss or improvement of BCVA as determined by the mean change of BCVA tested by ETDRS chart compared to baseline in 12 months period, when intravitreal ranibizumab is applied monthly in the first 3 months period, and later when visual acuity (VA) decreases with more than 5 letters at any visit performed monthly.	12 months	No
Secondary	Efficacy assessed by change in macular thickness	The efficacy of treatment concerning change of anatomical structure of macular region detected by Optical Coherence Tomography (OCT) - the mean change of macular thickness (micron) at each months of 1 year period.	12 months with monthly assessment	No