Evaluation of the Treat-and-extend Scheme in Patients With Retinal Vein Occlusion (RVO) With and Without LASER Treatment of Ischaemic Retinal Areas

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of the Treat-and-extend Scheme in Patients With Retinal Vein Occlusion (RVO) With and Without LASER Treatment of Ischaemic Retinal Areas

Conditions
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Central Retinal Vein Occlusion With Macular Edema

Intervention / Treatment
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* Drug: Ranibizumab
* Device: Laser


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ranibizumab<br>Patients receive intravitreal injections of 0,5 mg Ranibizumab (Lucentis®) / injection following the treat-and-extend scheme for 12 months. | Drug: Ranibizumab<br> <br> * Other names: Lucentis;|
| Experimental: Ranibizumab + Laser<br>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. | Drug: Ranibizumab<br> <br> * Other names: Lucentis;Device: Laser<br> <br> * Other names: Visulas 532s Laser;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | within 12 months after first injection of Ranibizumab | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Injections |  | 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 | 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 | 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 | 4-9 weeks after last injection within |