Evaluation of the "Treat-and-extend" Scheme in Patients With Retinal Vein Occlusion (RVO) With and Without LASER Treatment of Ischaemic Retinal Areas (PEARL)
Primary Purpose
Central Retinal Vein Occlusion With Macular Edema
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ranibizumab
Laser
Sponsored by
About this trial
This is an interventional treatment trial for Central Retinal Vein Occlusion With Macular Edema
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Ranibizumab
Ranibizumab + Laser
Arm Description
Patients receive intravitreal injections of 0,5 mg Ranibizumab (Lucentis®) / injection following the "treat-and-extend" scheme for 12 months.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Number of Injections
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
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
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
Full Information
NCT ID
NCT02522897
First Posted
August 4, 2015
Last Updated
August 11, 2015
Sponsor
PD. Dr. med. Armin Wolf
Collaborators
University Hospital, Bonn
1. Study Identification
Unique Protocol Identification Number
NCT02522897
Brief Title
Evaluation of the "Treat-and-extend" Scheme in Patients With Retinal Vein Occlusion (RVO) With and Without LASER Treatment of Ischaemic Retinal Areas
Acronym
PEARL
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
January 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
PD. Dr. med. Armin Wolf
Collaborators
University Hospital, Bonn
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Retinal Vein Occlusion With Macular Edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ranibizumab
Arm Type
Active Comparator
Arm Description
Patients receive intravitreal injections of 0,5 mg Ranibizumab (Lucentis®) / injection following the "treat-and-extend" scheme for 12 months.
Arm Title
Ranibizumab + Laser
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Type
Device
Intervention Name(s)
Laser
Other Intervention Name(s)
Visulas 532s Laser
Primary Outcome Measure Information:
Title
Differences in the length of the treatment-free interval in patients with or without panretinal photocoagulation
Description
Length of the longest interval between reinjections that did not result in recurrence
Time Frame
within 12 months after first injection of Ranibizumab
Secondary Outcome Measure Information:
Title
Number of Injections
Time Frame
within 12 months after first injection of Ranibizumab
Title
Retinal thickness in µm measured by spectral domain (SD)-Optical coherence tomography (OCT) at end-of-study visit
Description
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
Time Frame
4-9 weeks after last injection within
Title
Visus at end-of-study visit
Description
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
Time Frame
4-9 weeks after last injection within
Title
Percentage of patients with retinal thickness of more than 220 µm in the OCT examination at the end-of-study visit
Description
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
Time Frame
4-9 weeks after last injection within
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Verena Dykstra, Dr.
Phone
+49 228 287 16360
Email
verena.dykstra@ukb.uni-bonn.de
First Name & Middle Initial & Last Name or Official Title & Degree
Almut Steinhagen, Dr.
Phone
+49 228 287 16029
Email
almut.steinhagen@ukb.uni-bonn.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armin Wolf, PD Dr.
Organizational Affiliation
Eye Clinic of the Ludwig Maximilians University of Munich
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the "Treat-and-extend" Scheme in Patients With Retinal Vein Occlusion (RVO) With and Without LASER Treatment of Ischaemic Retinal Areas
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