NCT04444492

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P25-P50 for phase_3

Timeline
19mo left

Started Aug 2020

Longer than P75 for phase_3

Geographic Reach
2 countries

15 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Aug 2020Nov 2027

First Submitted

Initial submission to the registry

June 19, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 23, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

August 25, 2020

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2027

Last Updated

March 26, 2025

Status Verified

March 1, 2025

Enrollment Period

7.3 years

First QC Date

June 19, 2020

Last Update Submit

March 25, 2025

Conditions

Central Retinal Vein Occlusion With Macular Edema

Keywords

retinal vein occlusion

Outcome Measures

Primary Outcomes (1)

  • Efficacy endpoint is the time to treatment success

    Time from randomisation until the date of last criteria-based intravitreal injection in case that thereafter a treatment-free period for (at least) 6 months was observed.

    up-to 29 months

Secondary Outcomes (3)

  • Best corrected visual acuity (BCVA)

    Month 29

  • Central subfield thickness (CST)

    Month 29

  • Number of ranibizumab injections

    Month 29

Other Outcomes (7)

  • Development of neovascularization(s)

    Month 24

  • The area of non-perfusion

    Month 24

  • Vessel density

    Month 24

  • +4 more other outcomes

Study Arms (2)

Ranibizumab+Laser-arm

EXPERIMENTAL

Ranibizumab injections and additional targeted laser

Drug: Ranibizumab InjectionDevice: Laser photocoagulation

Ranibizumab-arm

ACTIVE COMPARATOR

Only Ranibizumab injections

Drug: Ranibizumab Injection

Interventions

Ranibizumab InjectionDRUG

initial three injections of Ranibizumab - afterwards pro re nata monthly

Also known as: Lucentis
Ranibizumab+Laser-armRanibizumab-arm
Laser photocoagulationDEVICE

Areas of capillary non-perfusion will be treated with photocoagulation upto 4 times

Ranibizumab+Laser-arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • CRVO with ischemic maculopathy defined as diameter of the foveolar avascular zone larger than 2 optic disc diameters
  • Macular edema due to another etiology than retinal vein occlusion (e.g. diabetic maculopathy, uveitis, age related macular degeneration, Irvine-Gass syndrome)
  • History of idiopathic central serous chorioretinopathy
  • Presence of vitreoretinal interface disease (e.g. vitreomacular traction, epiretinal membrane), either on clinical examination or in OCT
  • An eye that, in the investigator's opinion, would not benefit from resolution of macular edema, such as eyes with foveal atrophy, dense pigmentary changes, or dense subfoveal hard exudates
  • Aphakia in the study eye
  • Scatter laser photocoagulation or macular photocoagulation in the study eye prior to study entry
  • Intraocular or periocular injection of steroids in the study eye prior to study entry
  • Previous use of an anti-VEGF drug in the study eye
  • Cataract surgery or any other intraocular surgery in the study eye within 3 months prior to study entry
  • Uncontrolled glaucoma (defined as intraocular pressure ≥ 30 mm Hg despite treatment with maximal anti-glaucoma medications)
  • History of stroke, myocardial infarction, transient ischemic attacks within 3 months prior to the study
  • Pregnancy (positive urine pregnancy test) or lactation
  • The presence of active malignancy, including lymphoproliferative disorders.
  • History of allergy to fluorescein or any component of the ranibizumab formulation
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Medizinische Universität Innsbruck, Klinik für Augenheilkunde und Optometrie

Innsbruck, 6020, Austria

NOT YET RECRUITING

Universitätsklinikum Carl Gustav Carus Dresden Klinik und Polyklinik für Augenheilkunde

Dresden, 01307, Germany

WITHDRAWN

Internationale Innovative Ophthalmochirurgie GbR, Klinik für Augenchirurgie

Düsseldorf, Germany

WITHDRAWN

Universitätsklinikum Klinik für Augenheilkunde Freiburg

Freiburg im Breisgau, 79106, Germany

RECRUITING

Universitätsklinikum Gießen, Klinik und Poliklinik für Augenheilkunde

Giessen, Germany

RECRUITING

Hannover MHH Universitätsklinik für Augenheilkunde

Hanover, 30625, Germany

RECRUITING

University Hospital of Leipzig Department of Ophthalmology

Leipzig, 04103, Germany

RECRUITING

Klinikum der Stadt Ludwigshafen Augenklinik

Ludwigshafen, 67063, Germany

RECRUITING

Universitätsklinikum Gießen und Marburg GmbH, Standort Marburg Klinik für Augenheilkunde

Marburg, 35043, Germany

RECRUITING

Ludwig-Maximilians-Universität München, Augenklinik

München, Germany

RECRUITING

Augenzentrum am St. Franziskus-Hospital Münster

Münster, 48145, Germany

RECRUITING

Universitätsklinikum Klinik für Augenheilkunde

Münster, 48149, Germany

WITHDRAWN

Universitätsklinikum Tübingen, Department für Augenheilkunde

Tübingen, Germany

RECRUITING

Universitätsklinikum Ulm, Klinik für Augenheilkunde

Ulm, Germany

RECRUITING

Augen-OP-Zentrum Zschopau, Praxis für Augenheilkunde

Zschopau, Germany

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Retinal Vein Occlusion

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Matus Rehak, Professor

    Department of Ophthalmology Justus-Liebig-Universität Giessen

    STUDY DIRECTOR

Central Study Contacts

Matus Rehak, Professor

CONTACT

0049 641 985 438 01matus.rehak@uk-gm.de

Yasmine Breitenstein

CONTACT

0049 341 97 16 247yasmine.breitenstein@zks.uni-leipzig.de

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
blinded BCVA assessor
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2020

First Posted

June 23, 2020

Study Start

August 25, 2020

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

November 30, 2027

Last Updated

March 26, 2025

Record last verified: 2025-03

Locations

DE(14)AU(1)