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Branch Retinal Vein OcclusionPhase 4RVOFVNCT01795209

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

A Phase 4 study testing Ranibizumab and Rescue laser in people with Branch Retinal Vein Occlusion and Macular Edema, run by Seoul National University Bundang Hospital at 2 sites in South Korea.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Branch Retinal Vein Occlusion, Macular Edema
What is being tested?
Ranibizumab and Rescue laser
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
19 participants
Where
2 sitesSouth Korea
Study dates
Jan 2013to Dec 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • Seoul National University Bundang Hospital

    Seongnam, Gyunggi-do, 463-707

  • Samsung Medical Center

    Seoul, 135-710

Other trials in South Korea

About this study

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

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.

Read the 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.

Being tested
Ranibizumab, Sham injection, Rescue laser
Keywords
Branch retinal vein occlusion, Macular edema, Ranibizumab
Medical subject headings
Retinal Vein Occlusion, Macular Edema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RanibizumabDrug

    Also called Lucentis(ranibizumab), 3mg/0.3ml

    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

  • Sham injectionDevice

    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

  • Rescue laserProcedure or surgery

    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

Study groups in NCT01795209
Study groupRoleWhat they receive
Ranibizumab groupExperimentalPatients will receive three monthly injections of 0.5 mg of Lucentis (0.05 ml), followed by retreatment/rescue laser as needed.
Receives: Drug: Ranibizumab; Procedure: Rescue laser
Standard of care groupSham comparatorPatients will receive three monthly sham injections, followed by retreatment/rescue laser as needed.
Receives: Device: Sham injection; Procedure: Rescue laser

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 1 year

Secondary outcomes (12)

  1. Mean change from baseline ETDRS letter score over time

    Measured: 6 months and 1 year

  2. Percentage of patients gaining 10 or more letters in ETDRS letter score from baseline BCVA

    Measured: 6 months and 1 year

  3. Percentage of patients gaining < 10 letters in ETDRS letter score from baseline BCVA

    Measured: 6 months and 1 year

  4. Percentage of patients losing < 10 letters in ETDRS letter score from baseline BCVA

    Measured: 6 months and 1 year

  5. Proportion of patients with who at least maintain baseline BCVA

    Measured: 6 months and 1 year

  6. Percentage of patients with central foveal thickness (CFT) of < 300 um

    Measured: 6 months and 1 year

  7. Safety outcomes

    Frequency, type, and severity of adverse reactions

    Measured: 6 months and 1 year

  8. Mean change from baseline CFT over time

    Measured: 6 months and 1 year

  9. Mean change from baseline in National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) distance activities subscale score

    Measured: 6 months and 1 year

  10. Mean change from baseline in contrast sensitivity

    Measured: 6 months and 1 year

  11. Mean change from baseline in multifocal electroretinogram (mfERG) P1 amplitude

    Measured: 6 months and 1 year

  12. Percentage of patients losing 10 or more letters in ETDRS letter score from baseline BCVA

    Measured: 6 months and 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2013 (estimated)
  2. Study startJan 2013
  3. Primary completionDec 2017
  4. Study completionDec 2017

Why it stopped: insufficient enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01795209
Sponsor's protocol ID
B-1207-162-005
Other IDs
B-1207-162-005
Acronym
RVOFV
Status last verified
Sep 2019
First submitted
18 Feb 2013
Last updated
19 Sep 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 20398941

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ranibizumab and Rescue laser in people with Branch Retinal Vein Occlusion and Macular Edema, run by Seoul National University Bundang Hospital at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: insufficient enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01795209, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.

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