EUCTR2015-003079-31-DE进行中（未招募）1 期
A PHASE 2/3, RANDOMIZED, DOUBLE-MASKED, SHAMCONTROLLED TRIAL OF QPI-1007 DELIVERED BY SINGLE OR MULTI-DOSE INTRAVITREAL INJECTION(S) TO SUBJECTS WITH ACUTE NONARTERITIC ANTERIOR ISCHEMIC OPTIC NEUROPATHY (NAION)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 800
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
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 164
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 656
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, as determined either by the site
- •investigator or at the Reading Center.
- •3. Prior episode of NAION in the study eye only.
- •4. Bilateral (simultaneous) NAION
- •5. NAION secondary to acute blood loss (e.g., due to surgery, trauma, or spontaneous
- •hemorrhage) or immediately following any surgery
- •6. Prior incisional or laser intraocular surgery in the study eye at any time.
- •Note: The following subset of surgeries are allowed within the windows specified for
- •each surgery type:
- •Corneal laser surgeries (e.g., laser-assisted in situ keratomileusis) performed more than 1 month prior to Day 1;
- •Laser capsulotomy performed more than 1 week prior to Day 1;
- •Cataract surgery performed more than 3 months prior to Day 1;
- •Glaucoma laser surgery (i.e., laser iridotomy, laser iridoplasty) performed for narrow anterior chamber angle (not for ocular hypertension or glaucoma) performed more than 1 month prior to Day 1;
- •Retinal laser surgeries for small peripheral retinal tears in the study eye performed more than 1 month prior to Day 1.
- •7. Any of the following Visual Field exclusions at Screening Visit (inconclusive visual fields should be sent to the Reading Center for adjudication) in the study eye:
- •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).
- •Note: Mild blepharitis is acceptable.
- •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
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