Proof of Concept Study of Re-treatment in BRVO With Ranibizumab Guided by OCT (RabOCT)
Primary Purpose
Branch Retinal Vein Occlusion
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Ranibizumab
Sponsored by
About this trial
This is an interventional treatment trial for Branch Retinal Vein Occlusion focused on measuring BRVO, Macular edema, Ranibizumab, re-treatment
Eligibility Criteria
Inclusion Criteria:
- Recurrence of macular edema defined as any kind of fluid accumulation in the macula (microcystic changes with or without increase of central retinal thickness) detected by OCT in the month 1 to 6 after the last Lucentis injection without any decrease of BCVA measured with ETDRS charts 2. Diagnosis of BRVO with macular edema treated with at least three intravitreally applied injections of ranibizumab after the up-load phase of treatment 3. Age ≥ 18 years 4. Ability and willingness to attend all scheduled visits and assessments 5. For sexually active women of childbearing potential, use of an appropriate form of contraception (or abstinence) for the duration of the study
Exclusion Criteria:
- Macular edema due to another etiology than retinal vein occlusion (e.g. diabetic maculopathy, uveitis, age related macular degeneration, Irvine-Gass syndrome)
- Evidence upon examination of vitreoretinal interface disease (e.g., vitreomacular traction, epiretinal membrane), either on clinical examination or OCT, thought to be contributing to macular edema
- Use of intraocular or periocular injection of steroids in the study eye (e.g., triamcinolone) prior to study entry
- History of cerebral vascular accident, myocardial infarction, transient ischemic attacks in last 6 months
- Pregnancy (positive pregnancy test) or lactation
- History of allergy to humanized antibodies or any component of the ranibizumab formulation
Sites / Locations
- Department of Ophthalmology, University Leipzig
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
OCT guided group
Standard treatment
Arm Description
Patients randomized to this group will get the intravitreal injection of 0.5 mg ranibizumab if the morphological macular changes for recurrence of macular edema (microcystic changes with or without increase of central retinal thickness) will be detected by OCT.
Patients randomized to this group will get the intravitreal injection of 0.5 mg ranibizumab according to the in SmPC defined re-treatment criteria (re-injection if decrease of BCVA will be detected).
Outcomes
Primary Outcome Measures
change of best corrected visual acuity (BCVA) measured in ETDRS letters
Secondary Outcome Measures
Central retinal thickness (CRT)
Number of applied ranibizumab injections
• Rates of patients developing a neovascularisation of the retina/ anterior segment
Assessment of safety: serious adverse events/ reactions; AEs/ARs
Full Information
NCT ID
NCT01968239
First Posted
October 18, 2013
Last Updated
November 30, 2018
Sponsor
University of Leipzig
1. Study Identification
Unique Protocol Identification Number
NCT01968239
Brief Title
Proof of Concept Study of Re-treatment in BRVO With Ranibizumab Guided by OCT
Acronym
RabOCT
Official Title
A Randomized, Controlled Interventional Phase 2b (Proof of Concept) Study of the Efficacy, Safety, and Tolerability of Repeated Intravitreal Administration of Ranibizumab Guided by Morphological Changes Documented by Optical Coherence Tomography (OCT) in Subjects With Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
October 2013 (Actual)
Primary Completion Date
June 17, 2016 (Actual)
Study Completion Date
December 20, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leipzig
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of the trial is to evaluate the efficacy and safety of intravitreal injections of ranibizumab for the treatment of macular edema due to BRVO if the re-treatment regimen is guided by morphological macular changes detected by OCT compared to re-treatment according to SmPC defined re-treatment criteria (in case of increase of CRT and concomitant decrease of BCVA).
Detailed Description
In a prospective, randomized, interventional, controlled phase IIb clinical the functional results of treatment with ranibizumab in patients with macular edema due to branch retinal vein occlusion when given according to morphological changes detected by OCT compared to standard re-treatment criteria according to SmPC
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Branch Retinal Vein Occlusion
Keywords
BRVO, Macular edema, Ranibizumab, re-treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OCT guided group
Arm Type
Experimental
Arm Description
Patients randomized to this group will get the intravitreal injection of 0.5 mg ranibizumab if the morphological macular changes for recurrence of macular edema (microcystic changes with or without increase of central retinal thickness) will be detected by OCT.
Arm Title
Standard treatment
Arm Type
Active Comparator
Arm Description
Patients randomized to this group will get the intravitreal injection of 0.5 mg ranibizumab according to the in SmPC defined re-treatment criteria (re-injection if decrease of BCVA will be detected).
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Intervention Description
comparison of different re-treatment criteria for intravitreal injection of ranibizumab
Primary Outcome Measure Information:
Title
change of best corrected visual acuity (BCVA) measured in ETDRS letters
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Central retinal thickness (CRT)
Time Frame
12 months
Title
Number of applied ranibizumab injections
Time Frame
12 months
Title
• Rates of patients developing a neovascularisation of the retina/ anterior segment
Time Frame
12 months
Title
Assessment of safety: serious adverse events/ reactions; AEs/ARs
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Recurrence of macular edema defined as any kind of fluid accumulation in the macula (microcystic changes with or without increase of central retinal thickness) detected by OCT in the month 1 to 6 after the last Lucentis injection without any decrease of BCVA measured with ETDRS charts 2. Diagnosis of BRVO with macular edema treated with at least three intravitreally applied injections of ranibizumab after the up-load phase of treatment 3. Age ≥ 18 years 4. Ability and willingness to attend all scheduled visits and assessments 5. For sexually active women of childbearing potential, use of an appropriate form of contraception (or abstinence) for the duration of the study
Exclusion Criteria:
Macular edema due to another etiology than retinal vein occlusion (e.g. diabetic maculopathy, uveitis, age related macular degeneration, Irvine-Gass syndrome)
Evidence upon examination of vitreoretinal interface disease (e.g., vitreomacular traction, epiretinal membrane), either on clinical examination or OCT, thought to be contributing to macular edema
Use of intraocular or periocular injection of steroids in the study eye (e.g., triamcinolone) prior to study entry
History of cerebral vascular accident, myocardial infarction, transient ischemic attacks in last 6 months
Pregnancy (positive pregnancy test) or lactation
History of allergy to humanized antibodies or any component of the ranibizumab formulation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matus Rehak, MD, Ph.D.
Organizational Affiliation
Department of Ophthalmology, University of Leipzig, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology, University Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Proof of Concept Study of Re-treatment in BRVO With Ranibizumab Guided by OCT
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