A Phase 4 interventional study of Ranibizumab and Laser in Central Retinal Vein Occlusion With Macular Edema, sponsored by PD. Dr. med. Armin Wolf. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-08-13.
Sponsored by PD. Dr. med. Armin Wolf · Phase 4, Interventional, and Treatment
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.
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.
This is the only study on the registry with PD. Dr. med. Armin Wolf as lead sponsor.
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Exclusion Criteria:
Patients receive intravitreal injections of 0,5 mg Ranibizumab (Lucentis®) / injection following the "treat-and-extend" scheme for 12 months.
Drug: Ranibizumab
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 · Device: Laser
Also known as: Lucentis
Also known as: Visulas 532s Laser
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
Time frame: within 12 months after first injection of Ranibizumab
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
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
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
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
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
No study locations are listed for this record.
This study is status unknown, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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