Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-30 @ 8:08 AM
Study NCT ID:
NCT07024732
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-17
First Post:
2025-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety and Tolerability Clinical Trial of PST-611 in Dry Age-related Macular Degeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Single ascending dose design with 2 sequential dose groups (low dose group followed by high dose group)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-09', 'studyFirstSubmitDate': '2025-06-05', 'studyFirstSubmitQcDate': '2025-06-09', 'lastUpdatePostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Tolerability', 'timeFrame': 'Screening to week 16', 'description': 'Ocular and non-ocular adverse events frequency and severity'}], 'secondaryOutcomes': [{'measure': 'Intraocular pressure', 'timeFrame': 'Screening to Week 16', 'description': 'Intraocular pressure measured in mmHg'}, {'measure': 'Best corrected visual acuity', 'timeFrame': 'Screening to Week 16', 'description': 'Best corrected visual acuity measured in ETDRS letters'}, {'measure': 'Slit lamp biomicroscopy examination', 'timeFrame': 'Screening to Week 16', 'description': 'Abnormal examination results will be recorded'}, {'measure': 'Dilated ophthalmoscopy examination', 'timeFrame': 'Screening to Week 16', 'description': 'Abnormal examination results will be recorded'}, {'measure': 'Color fundus photography', 'timeFrame': 'Screening to Week 16', 'description': 'Abnormal findings will be recorded'}, {'measure': 'Spectral Domain-Optical Coherence Tomography', 'timeFrame': 'Screening to Week 16', 'description': 'Abnormal findings will be recorded'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dry Age Related Macular Degeneration', 'PST-611'], 'conditions': ['Dry Age Related Macular Degeneration']}, 'referencesModule': {'references': [{'pmid': '32882879', 'type': 'RESULT', 'citation': 'Bigot K, Gondouin P, Benard R, Montagne P, Youale J, Piazza M, Picard E, Bordet T, Behar-Cohen F. Transferrin Non-Viral Gene Therapy for Treatment of Retinal Degeneration. Pharmaceutics. 2020 Sep 1;12(9):836. doi: 10.3390/pharmaceutics12090836.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this interventional study is to evaluate the safety and tolerability of single ascending doses of PST-611 in men and women over the age of 50 with dry age-related macular degeneration (AMD).\n\nThe main question it aims to answer is: Is PST-611-CT1 safe for participants?\n\nParticipants will:\n\n* Receive a single dose of PST-611\n* Will be followed up for a total of 16 weeks following PST-611 administration', 'detailedDescription': 'The maximum study duration per patient is 28 Weeks (including an up to 12 week screening period + 16 weeks of follow-up after treatment).\n\nThe study is a single ascending dose study that investigates two PST-611 dose levels (low and high doses) in 2 successive dose groups. The study will enroll up to 12 participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nSubjects must give written informed consent, be able to make the required trial visits and follow instructions.\n\nFemale and male subjects must be 50 years of age or older. Female subjects of childbearing potential must not be pregnant or breast-feeding and must have a negative urine pregnancy test at baseline and throughout the study. They must agree to practice at least one effective method of birth control following administration of study medication.\n\nIn the study eye, at least one of the following must be present at OCT and attributed to AMD, as evaluated by the Investigator: Incomplete RPE and Outer Retinal Atrophy (iRORA), or Complete RPE and Outer Retinal Atrophy (cRORA).\n\nBest-Corrected Visual Acuity (BCVA), must be 23 ETDRS letters (approximate Snellen equivalent 20/320) or better in the study eye.\n\nSubject's fellow eye BCVA must be 34 letters (approximate Snellen equivalent 20/200) or better.\n\nExclusion Criteria:\n\nBoth eyes: any active intraocular or periocular infection or inflammation (eg, infectious blepharitis, infectious conjunctivitis, keratitis, scleritis, endophthalmitis), or history of intraocular or periocular infection or inflammation in the 12 weeks (84 days) prior to the PST-611 administration.\n\nStudy eye: Any intraocular surgery (including cataract surgery) or intravitreal (IVT) or periocular corticosteroid injection within 12 weeks (84 days) prior to the PST-611 administration.\n\nStudy eye: Any anti-VEGF IVT treatment within 4 weeks (28 days) prior to PST-611 dosing OR subjects who have required and received regular monthly injections of anti-VEGF drugs in the months preceding the trial and would thus have a higher likelihood of requiring and anti-VEGF treatment within 28 days of the PST-611 administration.\n\nStudy eye: media opacity that interferes with fundus imaging or is likely to require surgery during the trial period.\n\nStudy eye: subject with history of glaucoma filtering surgery (e.g. trabeculectomy or aqueous shunt implant) or who underwent eye surgery within 12 weeks (84 days) of the PST-611 administration. Study eye: subject who has uncontrolled intraocular pressure of ≥ 25 mmHg in the SE at the screening and baseline visits."}, 'identificationModule': {'nctId': 'NCT07024732', 'briefTitle': 'A Safety and Tolerability Clinical Trial of PST-611 in Dry Age-related Macular Degeneration', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eyevensys'}, 'officialTitle': 'An Open-label Single Ascending Dose Safety and Tolerability Clinical Trial of PST-611 in Subjects With Dry Age-related Macular Degeneration', 'orgStudyIdInfo': {'id': 'PST-611-CT1'}, 'secondaryIdInfos': [{'id': '2024-519025-37-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active treatment', 'description': 'This arm consists of 2 dose groups receiving a single ascending dose of PST-611. These groups will be dosed sequentially, low dose followed by high dose.', 'interventionNames': ['Biological: PST-611']}], 'interventions': [{'name': 'PST-611', 'type': 'BIOLOGICAL', 'description': 'PST-611 is a naked plasmid DNA encoding human transferrin administered into the ciliary muscle', 'armGroupLabels': ['Active treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'contacts': [{'name': 'Christophe Chiquet, Pr', 'role': 'CONTACT', 'email': 'cchiquet@chu-grenoble.fr', 'phone': '+33 (0)4 76 76 55 66'}, {'name': 'Christophe Chiquet, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Grenoble-Hôpital Michallon', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Francine Behar-cohen, Pr', 'role': 'CONTACT', 'email': 'francine.cohen@aphp.fr', 'phone': '+33 (0)1 58 41 22 20'}, {'name': 'Francine Behar-Cohen, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Karine Bigot, PhD', 'role': 'CONTACT', 'email': 'karine.bigot@pulsesight.com', 'phone': '+33 (0)1 84 79 10 62'}], 'overallOfficials': [{'name': 'Karine Bigot, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'PulseSight Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eyevensys', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}