Neovascular Glaucoma Clinical Trial
— STRONGOfficial title:
Prospective, Randomised, Placebo-controlled, Double-masked, Three-armed Multi-centre Trial of Aganirsen Versus Vehicle in Patients After Ischaemic Central Retinal Vein Occlusion With a High Risk to Develop Neovascular Glaucoma
A prospective, randomised, placebo-controlled, double-masked, three-armed multi-centre phase II/III trial for the Study of a Topical Treatment of Ischaemic Central Retinal Vein Occlusion to Prevent Neovascular Glaucoma - the STRONG Study
Status | Not yet recruiting |
Enrollment | 333 |
Est. completion date | December 2019 |
Est. primary completion date | June 2019 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Subjects meeting all of the following criteria will be considered for enrolment to the trial: - Male or female = 18 years - IOP in the study eye = 21mmHg - Primary ischaemic CRVO or conversion to ischaemic CRVO in the study eye for no longer than 4 weeks - Best-corrected visual acuity (BCVA) ETDRS letter score < 35 (< 20/200 Snellen equivalent) in the study eye - = 10-disc area of retinal capillary obliteration on fluorescein fundus angiography in the study eye (central fundus: macular area as defined by the optic disc and the arcades, an approximate 6000 micron circle around the fovea) and/or large, confluent retinal haemorrhages in the study eye Must be accompanied by 4 or more out of 6 following criteria: - A relative afferent pupillary defect (with a normal fellow eye) - = 10 cotton-wool-spots in the study eye - Venous tortuosity in the study eye - Peripheral visual field defects corresponding to ischaemia (Goldmann perimeter or other semi-automatic kinetic methods) in the study eye - Engorged vessels on iris and/or in the chamber angle in the study eye - Detectable anterior chamber flare in the study eye Exclusion Criteria: Subjects presenting 1 or more of the following criteria will not be enrolled in the trial: - Ocular conditions with a poorer prognosis in the fellow eye than in the study eye - Primary or secondary glaucoma in the study eye - Prior or concomitant ocular treatment with anti-VEGF in the study eye (ranibizumab/bevacizumab is not allowed within the last 45 days, aflibercept within the last 90 days) before screening visit - Use of anti-VEGF treatment in the fellow eye during the trial - Previous use of intraocular corticosteroids at any time or use of periocular corticosteroids in the study eye within 90 days prior to screening visit - History of idiopathic or autoimmune uveitis in either eye - Presence of NVD, NVE or anterior segment neovascularisation (NVA or NVI) in the study eye - Previous PRP in the study eye - Intraocular surgery (other than intravitreal anti-VEGF treatment) or laser treatment in the study eye within the past 90 days before screening visit - Patients with a history of breast cancer |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Gene Signal SAS | Johannes Gutenberg University Mainz, Moorfields Eye Hospital NHS Foundation Trust, University Hospital of Cologne |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | NVG component | Co-primary I: NVG component scored dichotomously (NVG=yes/NVG=no) where "yes" is development of NVI, NVA, NVD, and/or NVE, or rescue treatment; "no" otherwise | Week 24 | No |
Primary | IOP component | Co-primary II: IOP component scored dichotomously (failure/success); "failure" is rise in IOP from baseline to week 24 of = 20% to > 21 or rescue treatment; "success" otherwise | Week 24 | No |
Secondary | Secondary NVG | The time to development of secondary NVG in the study eye up to week 24 (in case aganirsen does not totally inhibit but slows down the development of NVG). | 24 weeks | No |
Secondary | Anterior segment neovascularisation | The time to development of anterior segment neovascularisation (NVI or NVA), NVD or NVE in the study eye, requiring PRP or cryotherapy up to week 24. | 24 weeks | No |
Secondary | NVG Classification | NVG Classification at 24 weeks on a scale from 1 (non-NVG) to 6 (most advanced NVG) based on central reading of neovascularisation | 24 weeks | No |
Secondary | Visual Acuity | The change from baseline in BCVA (EDTRS letter score) in the study eye to week 24. | 24 weeks | Yes |
Secondary | Number of additional needed laser treatments and re-treatments in the study eye at up to week 24 | Number of additional needed laser treatments and re-treatments in the study eye at up to week 24 | 24 weeks | No |
Secondary | Required intensity of laser spots of additional laser treatments and re-treatments in the study eye at up to week 24 | Required intensity of laser spots of additional laser treatments and re-treatments in the study eye at up to week 24 | 24 weeks | No |
Secondary | Retinal non-perfusion area | The change from baseline in size of retinal non-perfusion areas in the study eye to week 24 | 24 weeks | No |
Secondary | Retinal Thickness | Absolute change from baseline in retinal thickness in the study eye, assessed by spectral domain optical coherence tomography (SD-OCT) at week 24 | 24 weeks | No |
Secondary | Quality of Life | The change from baseline in the NEI-VFQ-25 health questionnaire total score to week 24 | 24 weeks | No |
Secondary | Quality of Life on EQ-5D | The change from baseline in the EQ-5D health questionnaire score to week 24 | 24 weeks | No |
Secondary | Safety: Incidence of treatment-emergent Adverse Events | Incidence, causality and intensity of adverse events between the treatment arms | 24 weeks | Yes |
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