NCT01123564

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 14, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

May 14, 2010

Status Verified

May 1, 2010

Enrollment Period

2.1 years

First QC Date

May 12, 2010

Last Update Submit

May 13, 2010

Conditions

Retinal Vein OcclusionMacular Edema

Keywords

macular edema secondary to retinal vein occlusion

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Efficacy assessed by change in macular thickness

    12 months with monthly assessment

Study Arms (2)

Lucentis (ranibizumab)

EXPERIMENTAL
Drug: ranibizumab

Laser

ACTIVE COMPARATOR
Radiation: Argon laser treatment

Interventions

ranibizumabDRUG

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

Also known as: Lucentis intravitreal injection
Lucentis (ranibizumab)
Argon laser treatmentRADIATION

Conventional grid pattern argon laser treatment and panretinal argon laser photocoagulation in an as needed basis.

Also known as: Laser photocoagulation
Laser

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Debrecen Medical and Health Science Center Dept of Ophthalmology

Debrecen, H-4012, Hungary

RECRUITING

University of Pecs, Medical School, Department of Ophthalmology

Pécs, H-7624, Hungary

RECRUITING

MeSH Terms

Conditions

Retinal Vein OcclusionMacular Edema

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesMacular DegenerationRetinal Degeneration

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Zsolt Balla, MD PhD

    University of Pecs

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zsolt Balla, MD

CONTACT

+3672536141balla07@freemail.hu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 12, 2010

First Posted

May 14, 2010

Study Start

August 1, 2009

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

May 14, 2010

Record last verified: 2010-05

Locations

HU(2)