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

August 11, 2015 updated by: PD. Dr. med. Armin Wolf
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

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
Time Frame: within 12 months after first injection of Ranibizumab
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
Time Frame: within 12 months after first injection of Ranibizumab
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
Time Frame: 4-9 weeks after last injection within
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
Time Frame: 4-9 weeks after last injection within
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
Time Frame: 4-9 weeks after last injection within
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PD. Dr. med. Armin Wolf

Collaborators

University Hospital, Bonn

Investigators

  • Principal Investigator: Armin Wolf, PD Dr., Eye Clinic of the Ludwig Maximilians University of Munich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

August 4, 2015

First Submitted That Met QC Criteria

August 11, 2015

First Posted (Estimate)

August 13, 2015

Study Record Updates

Last Update Posted (Estimate)

August 13, 2015

Last Update Submitted That Met QC Criteria

August 11, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EXT-201302-Pearl

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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