Branch Retinal Vein OcclusionPhase 2RabOCTNCT01968239
Proof of Concept Study of Re-treatment in BRVO With Ranibizumab Guided by OCT
A Phase 2 study testing Ranibizumab in people with Branch Retinal Vein Occlusion, run by University of Leipzig at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Branch Retinal Vein Occlusion
- What is being tested?
- Ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2013to 20 Dec 2016
- Phase
- Phase 2
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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).
Read the 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
- Conditions
- Branch Retinal Vein Occlusion
- Being tested
- Ranibizumab
- Keywords
- BRVO, Macular edema, Ranibizumab, re-treatment
- 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
comparison of different re-treatment criteria for intravitreal injection of ranibizumab
| Study group | Role | What they receive |
|---|---|---|
| OCT guided group | Experimental | 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. Receives: Drug: Ranibizumab |
| Standard treatment | Active comparator | 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). Receives: Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of best corrected visual acuity (BCVA) measured in ETDRS letters
Measured: 12 months
Secondary outcomes (4)
Central retinal thickness (CRT)
Measured: 12 months
Number of applied ranibizumab injections
Measured: 12 months
• Rates of patients developing a neovascularisation of the retina/ anterior segment
Measured: 12 months
Assessment of safety: serious adverse events/ reactions; AEs/ARs
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2013 (estimated)
- Study startOct 2013
- Primary completion17 Jun 2016
- Study completion20 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Branch Retinal Vein OcclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PD Dr. habil. Matus Rehak, University of Leipzig
- Investigators
- Matus Rehak, MD, Ph.D., Principal investigator, Department of Ophthalmology, University of Leipzig, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968239
- Sponsor's protocol ID
- 201200543910
- Acronym
- RabOCT
- Status last verified
- Nov 2018
- First submitted
- 18 Oct 2013
- Last updated
- 3 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01968239
- Acronym / sponsor ID
- RabOCT / 201200543910
- Conditions
- Branch Retinal Vein Occlusion
- Keywords
- BRVO, Macular edema, Ranibizumab, re-treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- 17 Jun 2016 (actual)
- Study completion
- 20 Dec 2016 (actual)
- First posted
- 23 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OCT guided group | Experimental | Drug: RanibizumabPatients 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. |
| Standard treatment | Active comparator | Drug: RanibizumabPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ranibizumabcomparison of different re-treatment criteria for intravitreal injection of ranibizumab | Drug | OCT guided group, Standard treatment |
Primary outcome
change of best corrected visual acuity (BCVA) measured in ETDRS letters
Time frame: 12 months
4 secondary outcomes
Central retinal thickness (CRT)
Time frame: 12 months
Number of applied ranibizumab injections
Time frame: 12 months
• Rates of patients developing a neovascularisation of the retina/ anterior segment
Time frame: 12 months
Assessment of safety: serious adverse events/ reactions; AEs/ARs
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matus Rehak, MD, Ph.D. principal investigator
Department of Ophthalmology, University of Leipzig, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ranibizumab in people with Branch Retinal Vein Occlusion, run by University of Leipzig at 1 site in Germany.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 3 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
change of best corrected visual acuity (BCVA) measured in ETDRS letters (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2018.