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Trial record 46 of 81 for:    CRVO - Central Retinal Vein Occlusion

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

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ClinicalTrials.gov Identifier: NCT02522897
Recruitment Status : Unknown
Verified August 2015 by PD. Dr. med. Armin Wolf, Ludwig-Maximilians - University of Munich.
Recruitment status was:  Not yet recruiting
First Posted : August 13, 2015
Last Update Posted : August 13, 2015
Sponsor:
Collaborator:
University Hospital, Bonn
Information provided by (Responsible Party):
PD. Dr. med. Armin Wolf, Ludwig-Maximilians - University of Munich

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.

Condition or disease Intervention/treatment Phase
Central Retinal Vein Occlusion With Macular Edema Drug: Ranibizumab Device: Laser Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the "Treat-and-extend" Scheme in Patients With Retinal Vein Occlusion (RVO) With and Without LASER Treatment of Ischaemic Retinal Areas
Study Start Date : August 2015
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

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 Name: 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 Name: Lucentis

Device: Laser
Other Name: Visulas 532s Laser




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Number of Injections [ Time Frame: within 12 months after first injection of Ranibizumab ]
  2. 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

  3. 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. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02522897


Contacts
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Contact: Verena Dykstra, Dr. +49 228 287 16360 verena.dykstra@ukb.uni-bonn.de
Contact: Almut Steinhagen, Dr. +49 228 287 16029 almut.steinhagen@ukb.uni-bonn.de

Sponsors and Collaborators
PD. Dr. med. Armin Wolf
University Hospital, Bonn
Investigators
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Principal Investigator: Armin Wolf, PD Dr. Eye Clinic of the Ludwig Maximilians University of Munich

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Responsible Party: PD. Dr. med. Armin Wolf, PD Dr. med. Armin Wolf, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT02522897     History of Changes
Other Study ID Numbers: EXT-201302-Pearl
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
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Retinal Vein Occlusion
Retinal Degeneration
Retinal Diseases
Venous Thrombosis
Macular Edema
Macular Degeneration
Eye Diseases
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents