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

Central Retinal Vein Occlusion With Macular Edema Clinical Trial

— PEARL  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02522897
• Other study ID #: EXT-201302-Pearl
• Status: Not yet recruiting
• Phase: Phase 4
• First received: August 4, 2015
• Last updated: August 11, 2015
• Start date: August 2015
• Est. completion date: January 2018

Study information

• Verified date: August 2015
• Source: Ludwig-Maximilians - University of Munich
• Contact: Verena Dykstra, Dr.
• Phone: +49 228 287 16360
• Email: verena.dykstra[@]ukb.uni-bonn.de
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Central Retinal Vein Occlusion With Macular Edema
• Macular Edema
• Retinal Vein Occlusion

Intervention

Drug:
• Ranibizumab

Device:
• Laser

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
PD. Dr. med. Armin Wolf	University Hospital, Bonn

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of Injections		within 12 months after first injection of Ranibizumab	No
Secondary	Retinal thickness in µm measured by spectral domain (SD)-Optical coherence tomography (OCT) at end-of-study visit	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	No
Secondary	Visus at end-of-study visit	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	No
Secondary	Percentage of patients with retinal thickness of more than 220 µm in the OCT examination at the end-of-study visit	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	No