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Ranibizumab for Macular Edema Secondary to Branch Retinal Vein Occlusion in Patients With Fair Vision (RVOFV)

Primary Purpose

Branch Retinal Vein Occlusion, Macular Edema

Status
Terminated
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ranibizumab
Sham injection
Rescue laser
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Branch Retinal Vein Occlusion focused on measuring Branch retinal vein occlusion, Macular edema, Ranibizumab

Eligibility Criteria

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

Inclusion Criteria:

  1. Foveal center-involving macular edema secondary to BRVO diagnosed within 12 months before study enrollment
  2. ETDRS chart BCVA: 63 to 77 letters (20/32 to 20/50 Snellen equivalent)
  3. CFT >= 300 um (mean of measurements obtained at screening and Day 0)
  4. Signed consent informed
  5. male or female, age ≥18 years old

Exclusion Criteria:

  1. Prior episode of RVO: Past history of RVO in the study eye diagnosed before 1 year of study enrollment.
  2. BCVA improvement >10 letters between screening and Day 0
  3. History of other ocular diseases (e.g. diabetic retinopathy, age-related macular degeneration)
  4. Laser treatment within 3 months before baseline
  5. Intraocular corticosteroid use within 3 months before baseline
  6. Anti-vascular endothelial growth factor (VEGF) treatment in the study or fellow eye within 3 months before baseline
  7. Intraocular surgery other than cataract surgery, Cataract surgery within 6 months before baseline
  8. Stroke or myocardial infarction ≤3 months before baseline
  9. Pregnancy or plan to have baby in female

Sites / Locations

  • Seoul National University Bundang Hospital
  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Ranibizumab group

Standard of care group

Arm Description

Patients will receive three monthly injections of 0.5 mg of Lucentis (0.05 ml), followed by retreatment/rescue laser as needed.

Patients will receive three monthly sham injections, followed by retreatment/rescue laser as needed.

Outcomes

Primary Outcome Measures

Time to achieve an improvement of 10 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters in best-corrected visual acuity

Secondary Outcome Measures

Mean change from baseline ETDRS letter score over time
Percentage of patients gaining 10 or more letters in ETDRS letter score from baseline BCVA
Percentage of patients gaining < 10 letters in ETDRS letter score from baseline BCVA
Percentage of patients losing < 10 letters in ETDRS letter score from baseline BCVA
Proportion of patients with who at least maintain baseline BCVA
Percentage of patients with central foveal thickness (CFT) of < 300 um
Safety outcomes
Frequency, type, and severity of adverse reactions
Mean change from baseline CFT over time
Mean change from baseline in National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) distance activities subscale score
Mean change from baseline in contrast sensitivity
Mean change from baseline in multifocal electroretinogram (mfERG) P1 amplitude
Percentage of patients losing 10 or more letters in ETDRS letter score from baseline BCVA

Full Information

First Posted
February 18, 2013
Last Updated
September 18, 2019
Sponsor
Seoul National University Bundang Hospital
Collaborators
Samsung Medical Center, Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT01795209
Brief Title
Ranibizumab for Macular Edema Secondary to Branch Retinal Vein Occlusion in Patients With Fair Vision
Acronym
RVOFV
Official Title
Phase 4 Study of Ranibizumab for the Treatment of Visual Impairment Due to Macular Edema Secondary to Branch Retinal Vein Occlusion in Patients With Initial Fair Visual Acuity
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
insufficient enrollment
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
Collaborators
Samsung Medical Center, Novartis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine the effect of ranibizumab for the treatment of macular edema (ME) secondary to branch retinal vein occlusion (BRVO) in patients with initial fair visual acuity.
Detailed Description
Lucentis was approved for ME due to BRVO based on the results from BRAVO study. The inclusion criteria in BRAVO was "best corrected visual acuity (BCVA) 20/40 to 20/320". Therefore, the patients with VA better than 20/40 who are out of inclusion criteria of BRAVO study had no treatment and just wait to reach spontaneous improvement. But, there is unmet needs of these patients and, in actual clinical practice, many retina specialists treat these patients with Ranibizumab. These patients have been experiencing VA improvement after the injection. Based on these clinical backgrounds, the investigator wants to suggest the treatment guidelines in these patients group, which is, early treatment of ranibizumab would be effective and increase patients' QOL. In other words, there are many experiences in these cases among ophthalmologists, but there have been no clinical trials that can endorse the treatments. To confirm the efficacy of ranibizumab in patients with initial fair vision, the investigators started the prospective randomized clinical trial on the efficacy and safety of ranibizumab for the patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Branch Retinal Vein Occlusion, Macular Edema
Keywords
Branch retinal vein occlusion, Macular edema, Ranibizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ranibizumab group
Arm Type
Experimental
Arm Description
Patients will receive three monthly injections of 0.5 mg of Lucentis (0.05 ml), followed by retreatment/rescue laser as needed.
Arm Title
Standard of care group
Arm Type
Sham Comparator
Arm Description
Patients will receive three monthly sham injections, followed by retreatment/rescue laser as needed.
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis(ranibizumab), 3mg/0.3ml
Intervention Description
Loading dose: three monthly intravitreal injections of ranibizumab 0.5 mg Lucentis stop criteria: V/A ≥20/20 and complete disappearance of macular edema Retreatment: visual loss of 5 or more letter compared to previous visit
Intervention Type
Device
Intervention Name(s)
Sham injection
Intervention Description
Three monthly sham injections followed by retreatment (sham injections) as needed Stop criteria: V/A ≥20/20 and complete disappearance of macular edema Retreatment: visual loss of 5 or more letter compared to previous visit
Intervention Type
Procedure
Intervention Name(s)
Rescue laser
Intervention Description
In the Lucentis group: performed if BCVA < 20/40 or CFT ≥ 350um despite of 3 sessions of previous Lucenis injection from Month 6 In the standard of care group: performed if BCVA < 20/40 or CFT ≥ 350um from Month 3
Primary Outcome Measure Information:
Title
Time to achieve an improvement of 10 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters in best-corrected visual acuity
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Mean change from baseline ETDRS letter score over time
Time Frame
6 months and 1 year
Title
Percentage of patients gaining 10 or more letters in ETDRS letter score from baseline BCVA
Time Frame
6 months and 1 year
Title
Percentage of patients gaining < 10 letters in ETDRS letter score from baseline BCVA
Time Frame
6 months and 1 year
Title
Percentage of patients losing < 10 letters in ETDRS letter score from baseline BCVA
Time Frame
6 months and 1 year
Title
Proportion of patients with who at least maintain baseline BCVA
Time Frame
6 months and 1 year
Title
Percentage of patients with central foveal thickness (CFT) of < 300 um
Time Frame
6 months and 1 year
Title
Safety outcomes
Description
Frequency, type, and severity of adverse reactions
Time Frame
6 months and 1 year
Title
Mean change from baseline CFT over time
Time Frame
6 months and 1 year
Title
Mean change from baseline in National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) distance activities subscale score
Time Frame
6 months and 1 year
Title
Mean change from baseline in contrast sensitivity
Time Frame
6 months and 1 year
Title
Mean change from baseline in multifocal electroretinogram (mfERG) P1 amplitude
Time Frame
6 months and 1 year
Title
Percentage of patients losing 10 or more letters in ETDRS letter score from baseline BCVA
Time Frame
6 months and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Foveal center-involving macular edema secondary to BRVO diagnosed within 12 months before study enrollment ETDRS chart BCVA: 63 to 77 letters (20/32 to 20/50 Snellen equivalent) CFT >= 300 um (mean of measurements obtained at screening and Day 0) Signed consent informed male or female, age ≥18 years old Exclusion Criteria: Prior episode of RVO: Past history of RVO in the study eye diagnosed before 1 year of study enrollment. BCVA improvement >10 letters between screening and Day 0 History of other ocular diseases (e.g. diabetic retinopathy, age-related macular degeneration) Laser treatment within 3 months before baseline Intraocular corticosteroid use within 3 months before baseline Anti-vascular endothelial growth factor (VEGF) treatment in the study or fellow eye within 3 months before baseline Intraocular surgery other than cataract surgery, Cataract surgery within 6 months before baseline Stroke or myocardial infarction ≤3 months before baseline Pregnancy or plan to have baby in female
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyu Hyung Park, M.D.
Organizational Affiliation
Seoul National Univeristy Bundang Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Se Woong Kang, M.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyunggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
20398941
Citation
Campochiaro PA, Heier JS, Feiner L, Gray S, Saroj N, Rundle AC, Murahashi WY, Rubio RG; BRAVO Investigators. Ranibizumab for macular edema following branch retinal vein occlusion: six-month primary end point results of a phase III study. Ophthalmology. 2010 Jun;117(6):1102-1112.e1. doi: 10.1016/j.ophtha.2010.02.021. Epub 2010 Apr 15.
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Ranibizumab for Macular Edema Secondary to Branch Retinal Vein Occlusion in Patients With Fair Vision

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