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

NCT02522897 | Unknown Phase 4

• 1 other identifier: EXT-201302-Pearl
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Central Retinal Vein Occlusion With Macular Edema

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

  4-9 weeks after last injection within

• Visus at end-of-study visit

  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

  4-9 weeks after last injection within

Study Arms (2)

Ranibizumab

ACTIVE COMPARATOR

Patients receive intravitreal injections of 0,5 mg Ranibizumab (Lucentis®) / injection following the "treat-and-extend" scheme for 12 months.

Drug: Ranibizumab

Ranibizumab + Laser

EXPERIMENTAL

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

Interventions

Ranibizumab DRUG

Also known as: Lucentis

Ranibizumab; Ranibizumab + Laser

Laser DEVICE

Also known as: Visulas 532s Laser

Ranibizumab + Laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• PD. Dr. med. Armin Wolf: lead
• University Hospital, Bonn: collaborator

MeSH Terms

Interventions

Ranibizumab; Lasers

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Armin Wolf, PD Dr.

  Eye Clinic of the Ludwig Maximilians University of Munich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Verena Dykstra, Dr.

CONTACT

+49 228 287 16360; verena.dykstra@ukb.uni-bonn.de

Almut Steinhagen, Dr.

CONTACT

+49 228 287 16029; almut.steinhagen@ukb.uni-bonn.de

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD Dr. med. Armin Wolf

Study Record Dates

• First Submitted: August 4, 2015
• First Posted: August 13, 2015
• Study Start: August 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: August 13, 2015

Record last verified: 2015-08