Central Retinal Vein Occlusion With Macular EdemaPhase 4PEARLNCT02522897
Evaluation of the "Treat-and-extend" Scheme in Patients With Retinal Vein Occlusion (RVO) With and Without LASER Treatment of Ischaemic Retinal Areas
A Phase 4 study testing Ranibizumab and Laser in people with Central Retinal Vein Occlusion With Macular Edema, run by PD. Dr. med. Armin Wolf.
Trial summary
The purpose of this study is to determine if additional panretinal photocoagulation of ischemic areas following retinal vein occlusion (RVO) may reduce the rate of recurrence and allow longer treatment intervals in anti-Vascular Endothelial Growth Factor (VEGF) treatment following the "trea-and-extend" scheme. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Retinal Vein Occlusion With Macular Edema
- What is being tested?
- Ranibizumab and Laser
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Jan 2018
- 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
- retinal vein occlusion with OCT-diagnosed macular edema with a documented duration of 3 months or less
- age over 18
- documented maximal visual acuity of 0,5 ETDRS
- voluntary participation in this study as proven by written informed consent
- ability to follow study instructions and likely to attend and complete all required visits
- pre-menopausal female patients with childbearing potential must use an approved contraceptive method (Pearl index <1)
- pre-menopausal female patients with childbearing potential: a negative serum pregnancy test must be obtained prior to treatment start
- ischemic area of more than 5 pupillary distance (PD) in angiography
Who cannot join
- subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial
- patients with known allergy to Ranibizumab or ingredients of the injection solution
- treatment in another clinical trial with therapeutic intervention or use of any other investigational medicinal product (IMP) during the trial or within the 30 days before enrolment
- known or persistent abuse of medication, drugs or alcohol
- women who are pregnant or breast-feeding
- failure of laboratory inclusion criteria
Show all 18Show fewer
- diabetic retinopathy
- previous anti-VEGF (Lucentis ®, Avastin®, Eylea®) or LASER therapy due to RVO
- previous intravitreal steroid therapy
- status post excision of the vitreous body
- status post intraocular surgery within 3 months before enrolment
- established or suspected ocular or periocular infection
- evidence of giant cell arteriitis
- retinal hemorrhages that seem to prevent a Laser-treatment of ischemic areals within the following 12 weeks
- unregulated hypertension above 200/120 mmHg
- cerebral vascular occurence or myocardium infarct within 12 months before enrolment
- relevant systemic diseases that might be associated with elevated VEGF serum concentration
- active malignancies (status post successful treatment of malignancies is no exclusion criterion)
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this study is to determine if additional panretinal photocoagulation of ischemic areas following retinal vein occlusion (RVO) may reduce the rate of recurrence and allow longer treatment intervals in anti-Vascular Endothelial Growth Factor (VEGF) treatment following the "trea-and-extend" scheme.
Read the detailed description
Patients with macular edema following RVO receive an anti-VEGF treatment by injection of Ranibizumab for 12 months in the "treat-and-extend" scheme. Following this scheme, all patients receive a series of three injections at the interval of 4 weeks. Thereafter, the retreatment interval is determined by results of certain examinations.
The next control including a reinjection is scheduled with an extension of one week until the patient presents signs of recurrence. Assuming that by the time of recurrence the interval is too long, the next control (following a retreatment) is then scheduled one week sooner than the last control. Following this treatment schedule, the individualized retreatment interval is thereafter kept steady.
Half the patients receive an additional panretinal photocoagulation on visit 3 and / or 4. Aim of this study is to investigate if this additional panretinal photocoagulation may result in a longer individualized retreatment interval corresponding to a reduced rate of recurrence of macular edema.
- Being tested
- Ranibizumab, Laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Also called Lucentis
LaserDevice
Also called Visulas 532s Laser
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab | Active comparator | Patients receive intravitreal injections of 0,5 mg Ranibizumab (Lucentis®) / injection following the "treat-and-extend" scheme for 12 months. Receives: Drug: Ranibizumab |
| Ranibizumab + Laser | Experimental | Apart from receiving intravitreal injections of 0,5 mg Ranibizumab (Lucentis®) / injection following the "treat-and-extend" scheme for 12 months, patients receive a panretinal photocoagulation on visit 3 and / or 4. Receives: Drug: Ranibizumab; Device: Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in the length of the treatment-free interval in patients with or without panretinal photocoagulation
Length of the longest interval between reinjections that did not result in recurrence
Measured: within 12 months after first injection of Ranibizumab
Secondary outcomes (4)
Number of Injections
Measured: within 12 months after first injection of Ranibizumab
Retinal thickness in µm measured by spectral domain (SD)-Optical coherence tomography (OCT) at end-of-study visit
end-of-study visit is performed at individualized retreatment interval (can range from 4-9 weeks) after last injection within 12 months after first injection of Ranibizumab
Measured: 4-9 weeks after last injection within
Visus at end-of-study visit
end-of-study visit is performed at individualized retreatment interval (can range from 4-9 weeks) after last injection within 12 months after first injection of Ranibizumab
Measured: 4-9 weeks after last injection within
Percentage of patients with retinal thickness of more than 220 µm in the OCT examination at the end-of-study visit
end-of-study visit is performed at individualized retreatment interval (can range from 4-9 weeks) after last injection within 12 months after first injection of Ranibizumab
Measured: 4-9 weeks after last injection within
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Retinal Vein Occlusion With Macular EdemaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PD. Dr. med. Armin Wolf
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Bonn
- Responsible party
- Sponsor-investigator, PD. Dr. med. Armin Wolf, Ludwig-Maximilians - University of Munich
- Investigators
- Armin Wolf, PD Dr., Principal investigator, Eye Clinic of the Ludwig Maximilians University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522897
- Sponsor's protocol ID
- EXT-201302-Pearl
- Acronym
- PEARL
- Status last verified
- Aug 2015
- First submitted
- 4 Aug 2015
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the "Treat-and-extend" Scheme in Patients With Retinal Vein Occlusion (RVO) With and Without LASER Treatment of Ischaemic Retinal Areas
- ClinicalTrials.gov ID
- NCT02522897
- Acronym / sponsor ID
- PEARL / EXT-201302-Pearl
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- PD. Dr. med. Armin WolfUniversity, hospital or other
- Collaborators
- University Hospital, Bonn
- Study start
- Aug 2015
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 13 Aug 2015 (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 purpose of this study is to determine if additional panretinal photocoagulation of ischemic areas following retinal vein occlusion (RVO) may reduce the rate of recurrence and allow longer treatment intervals in anti-Vascular Endothelial Growth Factor (VEGF) treatment following the "trea-and-extend" scheme.
Detailed description
Patients with macular edema following RVO receive an anti-VEGF treatment by injection of Ranibizumab for 12 months in the "treat-and-extend" scheme. Following this scheme, all patients receive a series of three injections at the interval of 4 weeks. Thereafter, the retreatment interval is determined by results of certain examinations.
The next control including a reinjection is scheduled with an extension of one week until the patient presents signs of recurrence. Assuming that by the time of recurrence the interval is too long, the next control (following a retreatment) is then scheduled one week sooner than the last control. Following this treatment schedule, the individualized retreatment interval is thereafter kept steady.
Half the patients receive an additional panretinal photocoagulation on visit 3 and / or 4. Aim of this study is to investigate if this additional panretinal photocoagulation may result in a longer individualized retreatment interval corresponding to a reduced rate of recurrence of macular edema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab | Active comparator | Drug: RanibizumabPatients receive intravitreal injections of 0,5 mg Ranibizumab (Lucentis®) / injection following the "treat-and-extend" scheme for 12 months. |
| Ranibizumab + Laser | Experimental | Drug: Ranibizumab, Device: LaserApart from receiving intravitreal injections of 0,5 mg Ranibizumab (Lucentis®) / injection following the "treat-and-extend" scheme for 12 months, patients receive a panretinal photocoagulation on visit 3 and / or 4. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- retinal vein occlusion with OCT-diagnosed macular edema with a documented duration of 3 months or less
- age over 18
- documented maximal visual acuity of 0,5 ETDRS
- voluntary participation in this study as proven by written informed consent
- ability to follow study instructions and likely to attend and complete all required visits
Key exclusion criteria (18 listed)
- subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial
- patients with known allergy to Ranibizumab or ingredients of the injection solution
- treatment in another clinical trial with therapeutic intervention or use of any other investigational medicinal product (IMP) during the trial or within the 30 days before enrolment
- known or persistent abuse of medication, drugs or alcohol
- women who are pregnant or breast-feeding
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 |
|---|---|---|
| RanibizumabAlso: Lucentis | Drug | Ranibizumab, Ranibizumab + Laser |
| LaserAlso: Visulas 532s Laser | Device | Ranibizumab + Laser |
Primary outcome
Differences in the length of the treatment-free interval in patients with or without panretinal photocoagulation
Time frame: within 12 months after first injection of Ranibizumab
Length of the longest interval between reinjections that did not result in recurrence
4 secondary outcomes
Number of Injections
Time frame: within 12 months after first injection of Ranibizumab
Retinal thickness in µm measured by spectral domain (SD)-Optical coherence tomography (OCT) at end-of-study visit
Time frame: 4-9 weeks after last injection within
Visus at end-of-study visit
Time frame: 4-9 weeks after last injection within
Percentage of patients with retinal thickness of more than 220 µm in the OCT examination at the end-of-study visit
Time frame: 4-9 weeks after last injection within
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
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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.
Armin Wolf, PD Dr. principal investigator
Eye Clinic of the Ludwig Maximilians University of Munich
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ranibizumab and Laser in people with Central Retinal Vein Occlusion With Macular Edema, run by PD. Dr. med. Armin Wolf.
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 8 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Verena Dykstra, Dr. (+49 228 287 16360, verena.dykstra@ukb.uni-bonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in the length of the treatment-free interval in patients with or without panretinal photocoagulation (time frame: within 12 months after first injection of Ranibizumab). 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 13 Aug 2015.