EUCTR2015-003079-31-IT进行中（未招募）1 期
A PHASE 2/3, RANDOMIZED, DOUBLE-MASKED, SHAM-CONTROLLED TRIAL OF QPI-1007 DELIVERED BY SINGLE OR MULTI-DOSE INTRAVITREAL INJECTION(S) TO SUBJECTS WITH ACUTE NONARTERITIC ANTERIOR ISCHEMIC OPTIC NEUROPATHY (NAION) - A TRIAL OF QPI-1007 DELIVERED BY SINGLE OR MULTI-DOSE INTRAVITREAL INJECTION(S) TO SUBJECTS WITH AC
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 820
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Positive diagnosis of first episode of NAION in the study eye, with symptom onset within 14 days prior to Day 1. The NAION diagnosis requires all of the following:
- •Disc edema (observed and documented at the study site)
- •Visual field defects in the study eye consistent with optic neuropathy and mean deviation worse than -3.0 dB on Humphrey standard automated perimetry using theSITA standard 24-2 testing protocol
- •Relative afferent pupillary defect (unless the contralateral eye had previous NAION
- •or other optic nerve or retinal disease that is not an exclusion criterion)OCT image and VF pattern compatible with the diagnosis of NAION, as determined by a Central Reading Center.
- •2.-Subject is 50 to 80 years of age.
- •3.-Best-corrected visual acuity score in the study eye is better than or equal to 15 letter score, measured using the ETDRS visual acuity protocol at Day 1 prior to study drug administration/sham procedure
- •4.-Clear ocular media and able to undergo adequate pupil dilation to allow a good fundus examination in the study eye.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 93
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 372
排除标准
- •1. Present use or history of any treatment for the current episode of NAION, including systemic steroids or brimonidine. Traditional Chinese herbal medicine taken for the treatment of the current episode of NAION should be discontinued.
- •2. Macular disease, proliferative (or pre-proliferative) diabetic retinopathy, or other eye disease limiting visual acuity in the study eye only.
- •3. Prior episode of NAION in the study eye only.
- •4. Bilateral (simultaneous) NAION
- •5. NAION secondary to acute blood loss (due to surgery, trauma, or spontaneoushemorrhage) or immediately following any surgery.
- •6. Prior incisional or laser intraocular surgery at any time, other than corneal laser surgeries (e.g., laser-assisted in situ keratomileusis) within one month prior to, laser capsulotomy within one week prior to, or cataract surgery performed within 3 months prior to Day 1 in the study eye only.
- •Note: Glaucoma laser surgery (i.e., laser iridotomy, laser iridoplasty) performed for narrow anterior chamber angle (not for ocular hypertension or glaucoma) and retinallaser surgeries for small peripheral retinal tears in the study eye, if more than 1 month prior to Day 1, are acceptable
- •7.Visual Field exclusions at Screening Visit (inconclusive visual fields should be sent to the Reading Center for adjudication):
- •Less than 3 adjacent abnormal points (>0.5% significance) on the pattern deviation map and the total deviation map
- •Temporal or nasal field loss that respects vertical midline
- •Homonymous binocular field loss (other than bilateral altitudinal in a subject with prior NAION)
- •Heteronymous binocular field loss that is bitemporal
- •Only abnormality on the field is an enlarged blind spot
- •8. Pain on eye movement in either eye.
- •9. History of vitrectomy in the study eye only
- •10. History of vitreous hemorrhage in the study eye only.
- •11. History of retinal detachment in the study eye only
- •12. History of optic neuritis in either eye.
- •13. History of uveitis in either eye.
- •14. Any active inflammatory condition in the study eye only (e.g., scleritis, uveitis).
- •15. Any active infectious condition (e.g., conjunctivitis) in either eye.
- •16. Glaucoma or ocular hypertension in the study eye only.
- •17. Intraocular pressure (IOP) greater than 25 mmHg on Day 1 prior to masked study drug administration in the study eye only.
- •18. Present use of drugs known to cause optic nerve or retinal toxicity atDay 1/Randomization, such as:
- •chloroquine or hydroxychloroquine, ethambutol, Vigabatrin. Subjects who need to be prescribed any of these drugs during the course of the study will be discontinued from the trial.
- •19. Any other abnormality that, in the opinion of the Investigator, is suggestive of a disease other than NAION in the study eye only.
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