2025-524748-37-00招募中2 期
Randomized, Multicenter, Vehicle-Controlled, Double-Masked Study to Evaluate the Efficacy and Safety of Intranasal Cenegermin (Recombinant Human Nerve Growth Factor [rhNGF]) in Adult Participants with Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 156
- 试验地点
- 54
- 主要终点
- Improvement in Best Corrected Visual Acuity (BCVA), defined as a ≥ 15 letter gain from baseline to Week 24, measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
研究概览
简要总结
To evaluate the efficacy of intranasal cenegermin compared to vehicle on improving the visual acuity in participants with NAION.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •1.Participant must be 50 to 80 years of age inclusive, at the time of signing informed consent.
- •2.A clinical diagnosis of unilateral NAION in the study eye with symptom onset prior to the planned date for first dose administration, confirmed with all the following at screening visit: a. ONH edema b. Visual field pattern compatible with the diagnosis of NAION, confirmed by central reading center (CRC) assessment c. Visual field mean sensitivity ≥ 7 decibels and ≤ 30 decibels d. Optical coherence tomography (OCT) findings consistent with a diagnosis of NAION, according to CRC assessments e. Relative afferent pupillary defect in the study eye (not required if the fellow eye had previous NAION or other optic nerve or retinal disease that is not an exclusion criterion).
- •3.Participant must be eligible for randomization and receive the first dose within 14 days of symptom onset.
- •4.A BCVA score in the study eye of ≥ 15 letters and ≤ 65 letters measured using the ETDRS chart.
- •5.Sufficiently clear ocular media and adequate pupil dilation to enable assessment of the optic nerve and retina in both eyes.
- •6.Participant is capable of giving signed informed consent as described in the protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •7.Male and female participants are eligible to participate, with the following caveats for female participants: • Females are eligible if they are not pregnant or breastfeeding, and one of the following conditions applies: - Is a woman of childbearing potential (WOCBP) as defined in the protocol and using an acceptable contraceptive method as described in the protocol during the study treatment period (at a minimum of until 30 days after the last dose of study treatment). • A WOBCP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) at screening, confirmed by a negative urine pregnancy test at baseline prior to study treatment administration. - If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
排除标准
- •1.Bilateral NAION or sequential NAION with fellow eye involvement within 6 weeks of study eye involvement.
- •Amblyopia or any other potential cause of vision loss in study eye not associated with NAION.
- •Malignancy, defined as any of the following: a. Known or suspected ocular malignancy (eg, ocular surface, intraocular, ocular adnexa) b. Presence of malignancy or any other systemic disease that, in the opinion of the investigator, may interfere with the participant’s ability to comply with or complete the clinical study, including basal cell carcinoma of the head c. History of malignancy, as follows: i. Malignancy within the past 5 years requiring oncologic treatment (eg, surgery, chemotherapy, immunotherapy, or radiotherapy), except for non-facial basal cell carcinoma that has been adequately treated ii. Any history of CNS malignancy
- •12.Prior use or planned use during the study of any of the following prior to informed consent: a. Systemic corticosteroids within 1 month b. Intranasal drug products for more than 7 cumulative days within 1 month, except for intranasal saline sprays c. Any medication or supplement with presumed neuroprotective effect (eg, systemic nicotinamide, systemic memantine, topical apraclonidine, topical brimonidine) within 6 weeks d. Immunomodulatory therapy within 3 months e. Amiodarone within 12 months f. Chemotherapy within 3 years g. Radiation therapy of head or neck within 20 years h. Any history of medication or supplement with known risk of other optic neuropathy or retinal toxicity (eg, ethambutol, hydroxychloroquine, chloroquine)
- •13.Planned use of phosphodiesterase-5 (PDE-5) inhibitors during the study
- •Conditions that prevent the effective intranasal delivery of IMP: a. known history of nasal polyps, chronic sinusitis, anatomical abnormalities obstructing the nasal passages b. prior history of paranasal or endoscopic nasal procedures (eg, paranasal sinus surgery, endoscopic nasal surgery such as transsphenoidal resection of pituitary tumors)
- •Active substance use disorder or dependency, including but not limited to alcohol, illicit drugs, misuse of prescription medications; marijuana or cannabis-derived products.
- •Inability to obtain a reproducible BCVA measurement in the study eye, defined as at least 2 BCVA measurements (out of 2 or 3 obtained) that are within 5 letters of each other, according to protocol-defined procedures.
- •Participants who have enrolled in another clinical trial within 3 months prior to informed consent or who are scheduled to enroll in another clinical trial during this study.
- •History of adverse reactions or significant hypersensitivity to any drug or excipient used for the study.
- •Presence or history of any ocular or systemic disease, active psychiatric disease, or condition that, in the investigator’s opinion, may affect the efficacy or evaluation of study treatment, interfere with the interpretation of study results, or be incompatible study conduct, including adherence to the study visit schedule or ability to perform procedures.
- •Clinical evidence of temporal arteritis (giant cell arteritis) signs or symptoms, where any of the following applies: a. jaw claudication b. scalp tenderness c. temple tenderness overlying the temporal arteries d. pallid disc edema e. Two or more of the following: previous episodes of transient visual loss leading up to persistent visual loss, headache, proximal myalgias, anorexia, weight loss, fever
- •Abnormal laboratory findings suggestive of temporal arteritis (giant cell arteritis), in the absence of a known acute cause (eg, in absence of infection, anemia, trauma): a. C reactive protein (CRP) level > 2x the institutional upper limit of normal (ULN) OR b. Elevated erythrocyte sedimentation rate (ESR), defined as > age/2 mm/hr for males or > (age+10)/2 mm/hr for females OR c.Thrombocytosis, defined as a platelet count greater than > 450,000 uL on complete blood count.
- •Pain with eye movement
- •5.Hemoglobin level less than 10 g/dL
- •6.Intraocular pressure (IOP) greater than 25 mmHg in the study eye or history of glaucoma in the study eye.
- •7.Intermediate age-related macular degeneration (AMD) with subfoveal drusen, exudative AMD, or geographic atrophy in the study eye.
- •8.Uncontrolled diabetes mellitus (HbA1c ≥ 8.0%), any level of diabetic retinopathy, or previous pan-retinal laser photocoagulation or macular laser photocoagulation.
- •History or evidence of: a. Optic neuritis or intraocular inflammation (chronic or recurrent anterior uveitis, any intermediate uveitis, or any posterior uveitis) in either eye. b. Infectious, nutritional, hereditary, radiation-induced, neoplastic (tumor-related), toxic and mitochondrial optic neuropathies, or any active ocular infection in either eye. c. Multiple sclerosis, collagen vascular disease, other systemic chronic inflammatory disease, or chronic immunosuppressive disease.
研究组 & 干预措施
Cenegermin
Test
干预措施: Cenegermin (Drug)
Vehicle for cenegermin drug product
Placebo
干预措施: Vehicle for cenegermin drug product (Drug)
结局指标
主要结局
Improvement in Best Corrected Visual Acuity (BCVA), defined as a ≥ 15 letter gain from baseline to Week 24, measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
Improvement in Best Corrected Visual Acuity (BCVA), defined as a ≥ 15 letter gain from baseline to Week 24, measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
次要结局
- Change from baseline through Week 24 in visual field mean sensitivity, in a prespecified region consisting of at least 5 separate loci on visual field testing
- Change from baseline through Week 24 in BCVA as measured by the ETDRS chart.
- Change from baseline through Week 24 in visual field mean sensitivity in decibels.
- Change from baseline through Week 24 in ganglion cell layer-inner plexiform layer (GCL-IPL) thickness (μm) on optical coherence tomography (OCT).
研究者
Dompé Medical Expert
Scientific
Dompe' Farmaceutici S.p.A.
研究点 (54)
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