Long-term Need of Ranibizumab Injections With or Without Early Targeted Peripheral Laser Photocoagulation for Treatment of Macular Edema Due to Central Retinal Vein Occlusion

Who is this study for? Patients with Central Retinal Vein Occlusion With Macular Edema
What treatments are being studied? Ranibizumab Injection
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Intravitreal injections of Ranibizumab will be applied in all patients according to treatment guidelines. The experimental group will receive additional targeted laser photocoagulation of the peripheral areas of capillary non-perfusion (up to 4 laser treatments within 1st year of the study). Based on the long-term observation after CoRaLa I study an importantly shorter duration of treatment and a relevant reduction of the total number of re-injections in RL patients is expected.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Diagnosis of macular edema due to central retinal vein occlusion foveal thickness \> 250 μm (measured by OCT)

• Age \> 18 years

• Written informed consent of the patient

• BCVA score in the study eye between 24 letters (20/320) and 78 letters (20/25) measured in ETDRS chart

• History of CRVO no longer than 6 months

• Presence of capillary non-perfusion in peripheral retina larger than 5 disc areas documented in ultra wide-field fluorescein angiography

• Ability and willingness to attend all scheduled visits and assessments

Locations
Other Locations
Austria
Medizinische Universität Innsbruck, Klinik für Augenheilkunde und Optometrie
NOT_YET_RECRUITING
Innsbruck
Germany
Universitätsklinikum Carl Gustav Carus Dresden Klinik und Polyklinik für Augenheilkunde
WITHDRAWN
Dresden
Internationale Innovative Ophthalmochirurgie GbR, Klinik für Augenchirurgie
WITHDRAWN
Düsseldorf
Universitätsklinikum Klinik für Augenheilkunde Freiburg
RECRUITING
Freiburg Im Breisgau
Universitätsklinikum Gießen, Klinik und Poliklinik für Augenheilkunde
RECRUITING
Giessen
Hannover MHH Universitätsklinik für Augenheilkunde
RECRUITING
Hanover
University Hospital of Leipzig Department of Ophthalmology
RECRUITING
Leipzig
Klinikum der Stadt Ludwigshafen Augenklinik
RECRUITING
Ludwigshafen
Universitätsklinikum Gießen und Marburg GmbH, Standort Marburg Klinik für Augenheilkunde
RECRUITING
Marburg
Ludwig-Maximilians-Universität München, Augenklinik
RECRUITING
München
Augenzentrum am St. Franziskus-Hospital Münster
RECRUITING
Münster
Universitätsklinikum Klinik für Augenheilkunde
WITHDRAWN
Münster
Universitätsklinikum Tübingen, Department für Augenheilkunde
RECRUITING
Tübingen
Universitätsklinikum Ulm, Klinik für Augenheilkunde
RECRUITING
Ulm
Augen-OP-Zentrum Zschopau, Praxis für Augenheilkunde
ACTIVE_NOT_RECRUITING
Zschopau
Contact Information
Primary
Matus Rehak, Professor
matus.rehak@uk-gm.de
0049 641 985 438 01
Backup
Yasmine Breitenstein
yasmine.breitenstein@zks.uni-leipzig.de
0049 341 97 16 247
Time Frame
Start Date: 2020-08-25
Estimated Completion Date: 2027-11-30
Participants
Target number of participants: 110
Treatments
Experimental: Ranibizumab+Laser-arm
Ranibizumab injections and additional targeted laser
Active_comparator: Ranibizumab-arm
Only Ranibizumab injections
Sponsors
Collaborators: University of Leipzig
Leads: University of Giessen

This content was sourced from clinicaltrials.gov

Similar Clinical Trials