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Ranibizumab in Patients With Branch Retinal Vein Occlusion

Primary Purpose

Retinal Vein Occlusion

Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Lucentis
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Vein Occlusion focused on measuring lucentis, macular edema, branch retinal vein occlusion

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • male or female, at least 18 years of age.
  • ophthalmoscopic evidence of recent BRVO, that is, a history of 3 months.
  • macular edema secondary to BRVO in the study eye scheduled for intravittreal anti-VEGF as primary treatment.
  • retinal thickness of > 300 µm by OCT in the central subfield of the study eye at baseline.
  • VA decrease attributable to the edema.
  • written informed consent has been obtained.
  • female patients of childbearing potential must have a negative urine pregnancy test.

Exclusion Criteria:

  • Uncontrolled sytemic disease
  • Symptoms of a clinically relevant illness in the 3 weeks before the first study day
  • Any ocular condition that in the opinion of the investigator would prevent a 15-letter improvement in visual acuity (eg severe macular ischemia)
  • History of glaucoma, aphakie or presence of anterior chamber intraocular lens, active reinal neovascularisation, choroidal neovascularisation, significant cataract, presence of rubeosis iridis, any ocular infection, history of pars plana vitrectomy, anticipated need for ocular surgery in the study eye during the study perios.
  • contraindication to pupil dilation known allergy or contraindication to the use of fluorescein.

Sites / Locations

  • Vienna General Hospital

Outcomes

Primary Outcome Measures

Main outcome measure: Retinal vessel diameters

Secondary Outcome Measures

Secondary outcome measures: Retrobulbar flow velocities, best-corrected visual acuity, macular sensitivity, objective functional response, anatomic changes in the macula region, angiographical outcomes.

Full Information

First Posted
December 7, 2009
Last Updated
December 7, 2009
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT01027481
Brief Title
Ranibizumab in Patients With Branch Retinal Vein Occlusion
Official Title
Response of Retinal Vessels to Anti Vascular Endothelial Growth Factor (VEGF) Treatment in Patients With Branch Retinal Vein Occlusion (BRVO)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In a recent study we could show that the early retinal venous vasoconstriction after grid photocoagulation in branch retinal vein occlusion (BRVO) is closely correlated to the visual outcome after three months. This could be of clinical importance, because the degree of vasoconstriction might be an early marker of treatment success, compatible with the idea that hypoxia is the major trigger of VEGF in BRVO. The present study evaluates the response of retinal vessel diameters to anti VEGF treatment with lucentis in patients with BRVO. This is done in an effort to gain insight into the retinal hemodynamic consequences of anti VEGF treatment in BRVO. The hypothesis that anti VEGF treatment is associated with a vasoconstrictor response in retinal vessel in patients with BRVO is tested.
Detailed Description
To investigate the response of retinal vessel diameters to lucentis treatment in patients with BRVO and to correlate these changes with changes in functional outcome after 3 months. Pilot study in patients scheduled for intravitreal anti-VEGF (Lucentis™) treatment with BRVO 30 patients with BRVO scheduled for intravitreal anti-VEGF treatment Intravitreous administration of Ranibizumab (Lucentis ™) Main outcome measure: Retinal vessel diameters Secondary outcome measures: Retrobulbar flow velocities, best-corrected visual acuity, macular sensitivity assessed with Microperimetry, objective functional response assessed with mfERG, anatomic changes in the macula region as assessed with StratusOCT and prototype of a Cirrus-OCT(which is available at the Department of Ophthalmology, Medical University of Vienna), angiographical outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Vein Occlusion
Keywords
lucentis, macular edema, branch retinal vein occlusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lucentis
Other Intervention Name(s)
RANIBIZUMAB (Lucentis 0.05 ml, Novartis)
Intervention Description
intravitreally administration of 0.05 ml Lucentis
Primary Outcome Measure Information:
Title
Main outcome measure: Retinal vessel diameters
Time Frame
weeks 1, 4 and 16
Secondary Outcome Measure Information:
Title
Secondary outcome measures: Retrobulbar flow velocities, best-corrected visual acuity, macular sensitivity, objective functional response, anatomic changes in the macula region, angiographical outcomes.
Time Frame
weeks 1,4 and16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: male or female, at least 18 years of age. ophthalmoscopic evidence of recent BRVO, that is, a history of 3 months. macular edema secondary to BRVO in the study eye scheduled for intravittreal anti-VEGF as primary treatment. retinal thickness of > 300 µm by OCT in the central subfield of the study eye at baseline. VA decrease attributable to the edema. written informed consent has been obtained. female patients of childbearing potential must have a negative urine pregnancy test. Exclusion Criteria: Uncontrolled sytemic disease Symptoms of a clinically relevant illness in the 3 weeks before the first study day Any ocular condition that in the opinion of the investigator would prevent a 15-letter improvement in visual acuity (eg severe macular ischemia) History of glaucoma, aphakie or presence of anterior chamber intraocular lens, active reinal neovascularisation, choroidal neovascularisation, significant cataract, presence of rubeosis iridis, any ocular infection, history of pars plana vitrectomy, anticipated need for ocular surgery in the study eye during the study perios. contraindication to pupil dilation known allergy or contraindication to the use of fluorescein.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Sacu, Ass. Prof.
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vienna General Hospital
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
21051706
Citation
Sacu S, Pemp B, Weigert G, Matt G, Garhofer G, Pruente C, Schmetterer L, Schmidt-Erfurth U. Response of retinal vessels and retrobulbar hemodynamics to intravitreal anti-VEGF treatment in eyes with branch retinal vein occlusion. Invest Ophthalmol Vis Sci. 2011 May 9;52(6):3046-50. doi: 10.1167/iovs.10-5842.
Results Reference
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Ranibizumab in Patients With Branch Retinal Vein Occlusion

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