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

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ClinicalTrials.gov Identifier: NCT01795209
Recruitment Status : Terminated (insufficient enrollment)
First Posted : February 20, 2013
Last Update Posted : September 19, 2019
Sponsor:
Collaborators:
Samsung Medical Center
Novartis
Information provided by (Responsible Party):
Kyu Hyung Park, Seoul National University Bundang Hospital

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.

Condition or disease Intervention/treatment Phase
Branch Retinal Vein Occlusion Macular Edema Drug: Ranibizumab Device: Sham injection Procedure: Rescue laser Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : January 2013
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Ranibizumab

Arm Intervention/treatment
Experimental: Ranibizumab group
Patients will receive three monthly injections of 0.5 mg of Lucentis (0.05 ml), followed by retreatment/rescue laser as needed.
Drug: Ranibizumab

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

Other Name: Lucentis(ranibizumab), 3mg/0.3ml

Procedure: Rescue laser

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


Sham Comparator: Standard of care group
Patients will receive three monthly sham injections, followed by retreatment/rescue laser as needed.
Device: Sham injection

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


Procedure: Rescue laser

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 Measures :
  1. 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 Measures :
  1. Mean change from baseline ETDRS letter score over time [ Time Frame: 6 months and 1 year ]
  2. Percentage of patients gaining 10 or more letters in ETDRS letter score from baseline BCVA [ Time Frame: 6 months and 1 year ]
  3. Percentage of patients gaining < 10 letters in ETDRS letter score from baseline BCVA [ Time Frame: 6 months and 1 year ]
  4. Percentage of patients losing < 10 letters in ETDRS letter score from baseline BCVA [ Time Frame: 6 months and 1 year ]
  5. Proportion of patients with who at least maintain baseline BCVA [ Time Frame: 6 months and 1 year ]
  6. Percentage of patients with central foveal thickness (CFT) of < 300 um [ Time Frame: 6 months and 1 year ]
  7. Safety outcomes [ Time Frame: 6 months and 1 year ]
    Frequency, type, and severity of adverse reactions

  8. Mean change from baseline CFT over time [ Time Frame: 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 [ Time Frame: 6 months and 1 year ]
  10. Mean change from baseline in contrast sensitivity [ Time Frame: 6 months and 1 year ]
  11. Mean change from baseline in multifocal electroretinogram (mfERG) P1 amplitude [ Time Frame: 6 months and 1 year ]
  12. Percentage of patients losing 10 or more letters in ETDRS letter score from baseline BCVA [ Time Frame: 6 months and 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01795209


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyunggi-do, Korea, Republic of, 463-707
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Seoul National University Bundang Hospital
Samsung Medical Center
Novartis
Investigators
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Principal Investigator: Kyu Hyung Park, M.D. Seoul National Univeristy Bundang Hospital
Principal Investigator: Se Woong Kang, M.D. Samsung Medical Center
Publications:
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Responsible Party: Kyu Hyung Park, Associate Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01795209    
Other Study ID Numbers: B-1207-162-005
B-1207-162-005 ( Other Identifier: Seoul National University Bundang Hospital )
First Posted: February 20, 2013    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Keywords provided by Kyu Hyung Park, Seoul National University Bundang Hospital:
Branch retinal vein occlusion
Macular edema
Ranibizumab
Additional relevant MeSH terms:
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Macular Edema
Retinal Vein Occlusion
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents