Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
Study NCT ID:
NCT01657669
Status:
UNKNOWN
Last Update Posted:
2017-10-27
First Post:
2012-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Short-term Clinical Effects of Intravitreal Aflibercept Injection 2.0mg as a Predictor of Long-term Results
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-26', 'studyFirstSubmitDate': '2012-08-02', 'studyFirstSubmitQcDate': '2012-08-03', 'lastUpdatePostDateStruct': {'date': '2017-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resolution time of intraretinal cysts and sub retinal fluid on OCT', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Mean change in OCT central foveal thickness', 'timeFrame': '12 months'}, {'measure': 'The percentage of subjects with no fluid on OCT', 'timeFrame': '12 months'}, {'measure': 'The percentage of subjects who lose less than 15 letters of visual acuity', 'timeFrame': '12 months'}, {'measure': 'The percentage of subjects who gain greater than or equal to 15 letters of visual acuity', 'timeFrame': '12 months'}, {'measure': 'Mean change in visual acuity', 'timeFrame': '12 months'}, {'measure': 'Mean change in macular volume', 'timeFrame': '12 months'}, {'measure': 'Quantitative change in area (microns) from baseline in choroidal neovascular lesion characteristics/size as measured by ICG/FA/Fundus photos', 'timeFrame': '12 months'}, {'measure': 'Mean number of injections of 2.0 mg intravitreal aflibercept injection', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Choroidal neovascularization due to AMD'], 'conditions': ['Age Related Macular Degeneration']}, 'referencesModule': {'references': [{'pmid': '26599244', 'type': 'DERIVED', 'citation': 'Liu EM, Shah G, Blinder KJ, Smith BT, Thomas MA. Intravitreal Aflibercept for Neovascular AMD: Short-Term Clinical Effects of Intravitreal Aflibercept Injection as a Predictor of Long-Term Results. Ophthalmic Surg Lasers Imaging Retina. 2015 Nov-Dec;46(10):1021-7. doi: 10.3928/23258160-20151027-06.'}]}, 'descriptionModule': {'briefSummary': 'This is an open label study to evaluate 2.0 mg intravitreal aflibercept injection administered in subject who have active choroidal neovascularization due to Age Related Macular Degeneration (AMD).', 'detailedDescription': 'Twenty (20) consented participant who meet the inclusion criteria will be enrolled to be followed for 48 weeks. All subjects will receive 2.0 mg intravitreal aflibercept injections with three initial monthly doses, and mandatory doses at Weeks 16, 24, 32, and 40. Dosing at monthly intervals is allowed if needed in the opinion of the investigator based on presence of fluid on Optical Coherence Tomography (OCT) and/or a decrease in visual acuity of greater than or equal to 5 letters from the best previous visit. Only one eye will be enrolled in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAbility to provide written informed consent and comply with study assessments for the full duration of the study.\n\nAge 50 years and above.\n\nChoroidal neovascularization secondary to AMD with central retinal thickness greater than or equal to 300um.\n\nBest corrected visual acuity in the study eye between 20/40 and 20/400 using an ETDRS chart -\n\nExclusion Criteria:\n\nPregnancy (positive urine pregnancy test) or lactation.\n\nPremenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.\n\nParticipation in a study or an investigational drug or device within the past 30 days prior to enrolling in the study.\n\nPresence of significant subfoveal fibrosis or atrophy.\n\nPreviously treated subjects:\n\nPrior treatment with anti-VEGF therapy in the study eye within 28 days of baseline More than six (6) prior treatments with anti-VEGF therapy in the study eye within 1 year.\n\nPrior treatment with PDT within the past 3 months or more than 2 prior PDT treatments.\n\nPrior treatment with intravitreal aflibercept injection Prior treatment with triamcinolone in the study eye within 6 months of baseline.\n\nPrior treatment with dexamethasone in the study eye within 30 days prior to baseline.\n\nIntraocular surgery (including cataract surgery)in the study eye within 2 months preceding baseline\n\nHistory of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye.\n\nActive intraocular inflammation (grade trace or above) in the study eye\n\nCurrent vitreous hemorrhage in the study eye\n\nHistory of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye.\n\nActive infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.\n\nUncontrolled glaucoma in the study eye (defined as IOP greater than or equal to 30 mmHg despite treatment with anti-glaucoma medication)\n\nHistory of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment.\n\nHistory of allergy to fluorescein, ICG or iodine, not amenable to treatment\n\nHistory of retinal pigment epithelial tear or rip.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01657669', 'briefTitle': 'Short-term Clinical Effects of Intravitreal Aflibercept Injection 2.0mg as a Predictor of Long-term Results', 'organization': {'class': 'OTHER', 'fullName': 'Retina Research Institute, LLC'}, 'officialTitle': 'Short-term Clinical Effects of Intravitreal Aflibercept Injection 2.0mg as a Predictor of Long-term Results', 'orgStudyIdInfo': {'id': 'GS-01-12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Intravitreal Aflibercept injection', 'description': 'Intravitreal Aflibercept injection 2.0 mg dosed every 4 weeks (monthly) for the first 3 months followed by 2.0 mg (0.05mg) via intravitreal injection once every 8 weeks (2 months).', 'interventionNames': ['Drug: Intravitreal Aflibercept injection']}], 'interventions': [{'name': 'Intravitreal Aflibercept injection', 'type': 'DRUG', 'description': 'Intravitreal Aflibercept injection 2.0 mg dosed every 4 weeks (monthly) for the first 3 months followed by 2.0 mg (0.05mL) via intravitreal injection once every 8 weeks (2 months). Dosing at monthly intervals is allowed if needed in the opinion of the investigator based on presence of fluid on OCT and/or a decrease in visual acuity of 5 letters or more from the best previous visit.', 'armGroupLabels': ['Intravitreal Aflibercept injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63128', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'The Retina Institute', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'The Retina Institute', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '78503', 'city': 'McAllen', 'state': 'Texas', 'country': 'United States', 'facility': 'Valley Retina Institute', 'geoPoint': {'lat': 26.20341, 'lon': -98.23001}}], 'overallOfficials': [{'name': 'Gaurav K. Shah, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Retina Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Retina Research Institute, LLC', 'class': 'OTHER'}, 'collaborators': [{'name': 'Valley Retina Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Gaurav K. Shah, MD, Principal Investigator', 'investigatorFullName': 'Rhonda Weeks', 'investigatorAffiliation': 'Retina Research Institute, LLC'}}}}