The LEAVO study

Phase 3

Completed

• Conditions: Macula odema due to central retinal vein occlusion; Eye Diseases; Retinal vascular occlusion, central

• Registration Number: ISRCTN13623634
• Lead Sponsor: Moorfields Eye Hospital (UK)

Brief Summary

2016 protocol in: https://www.thelancet.com/protocol-reviews/14PRT-06545 2019 results in https://www.ncbi.nlm.nih.gov/pubmed/31465100 (added 01/11/2019) 2021 results in https://pubmed.ncbi.nlm.nih.gov/34132192/ (added 17/06/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-26
• Study Completion: 2018-11-30
• Last Update Posted: 28 June 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 463

Inclusion Criteria

1. Subjects of either sex aged = 18 years
2. Clinical diagnosis of centre-involving macular oedema (MO) due to CRVO
3. CRVO of = 12 months duration
4. Best corrected visual acuity in the study eye = 19 and = 73 ETDRS letters (approximate Snellen VA 3/60 to VA 6/12)
5. Best corrected visual acuity in the non-study eye = 14 ETDRS letters (approximate Snellen VA = 2/60).
6. SD-OCT central subfield thickness (CST) > 320µm (Spectralis) predominantly due to MO secondary to CRVO in the study eye. See appendix 1 for equivalent CST value for alternative SD-OCT machines.
7. Media clarity, pupillary dilatation and subject cooperation sufficient for adequate fundus imaging of the study eye
8. In cases of bilateral CRVO, if both eyes are potentially eligible, unless the patient prefers otherwise the worst seeing eye will be recruited

Exclusion Criteria

Current exclusion criteria as of 13/08/2018:
The following apply to the study eye only and to the non-study eye only where specifically stated:
1. Macular oedema considered to be due to a cause other than CRVO (e.g. diabetic macular oedema, Irvine-Gass syndrome).
2. An ocular condition is present that, in the opinion of the investigator, might affect macular oedema or alter visual acuity during the course of the study (e.g. vitreomacular traction)
3. Any previously documented diabetic retinopathy or diabetic macular oedema in the study eye at baseline clinical examination of the study eye.
4. Moderate or severe non proliferative diabetic retinopathy (NPDR) or quiescent, treated or active proliferative diabetic retinopathy (PDR) or macular oedema in the non-study eye. Note: Mild NPDR only is permissible in the non-study eye.
5. History of treatment for MO due to CRVO in the past 90 days with intravitreal or peribulbar corticosteroids or in the last 60 days with anti-VEGF drugs or >6 prior anti-VEGF treatments in the previous 12 months.
6. Active iris or angle neovascularisation, neovascular glaucoma, untreated NVD, NVE and vitreous haemorrhage or treatment for these conditions in the last 1 month.
7. Uncontrolled glaucoma [>30mmHg], either untreated or on anti-glaucoma medication at screening.
8. Any active periocular or intraocular infection or inflammation (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis).

Systemic exclusion criteria:
9. Uncontrolled blood pressure defined as a systolic value > 170mmHg and diastolic value > 110mmHg.
10. Myocardial infarction, stroke, transient ischaemic attack, acute congestive cardiac failure or any acute coronary
event < 3 months before randomisation
11. Women of child bearing potential unless using effective methods of contraception throughout the study and for 6 months after their last injection for the trial. Effective contraception is defined as one of the following:
11.1. Barrier method: condoms or occlusive cap with spermicides
11.2. True abstinence: When it is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
11.3. Have had tubal ligation or bilateral oophorectomy (with or without hysterectomy)
11.4. Male partner sterilisation. The vasectomised male partner should be the only partner for the female participant
11.5. Use of established oral, injected or implanted hormonal methods of contraception and intrauterine device
12. Pregnant or lactating women.
13. Males who do not agree to an effective form of contraception for the duration of the study and for 6 months after their last injection for the trial
14. Hypersensitivity to the active ingredients aflibercept, bevacizumab or ranibizumab or any of the excipients of these drugs
15. Hypersensitivity to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanised antibodies
16. A condition that, in the opinion of the investigator, would preclude participati

Study & Design

• Study Type: Interventional
• Study Design: Not specified