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Photosensitizer
ICG-Guided Photodynamic Therapy for Treatment of Retinal Capillary Abnormalities: A Pilot Study (ICGguidedPDT Trial)
N/A
Waitlist Available
Led By Lawrence A. Yannuzzi, M.D.
Research Sponsored by Manhattan Eye, Ear & Throat Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-2 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
The purpose of this research is to use an approved drug(Visudyne) for neovascular age-related macular degeneration, which is essentially choroidal neovascularization for permeability and vascular proliferation for the retinal circulation, to treat another permeable abnormality - retinal capillary abnormalities - located eccentric to the central portion of the macula or in the foveal region.
Eligible Conditions
- Retinal Vascular Disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Improvement and/or stabilization of disease.
Side effects data
From 2017 Phase 4 trial • 333 Patients • NCT0212095016%
Viral upper respiratory tract infection
6%
Conjunctival haemorrhage
6%
Vitreous floaters
4%
Dry eye
4%
Intraocular pressure increased
4%
Hypertension
4%
Visual acuity reduced
3%
Retinal pigment epithelial tear
2%
Ocular hypertension
1%
Cataract
1%
Ileus
1%
Large intestine perforation
1%
Upper gastrointestinal haemorrhage
1%
Large intestine polyp
1%
Inguinal hernia strangulated
1%
Death
1%
Animal bite
1%
Fall
1%
Joint dislocation
1%
Radius fracture
1%
Rib fracture
1%
Scapula fracture
1%
Subdural haematoma
1%
Lumbar vertebral fracture
1%
Iron deficiency
1%
Osteoarthritis
1%
Osteonecrosis
1%
Colon cancer
1%
Gastric cancer
1%
Metastases to lung
1%
Neoplasm
1%
Thyroid neoplasm
1%
Haematuria
1%
Ureterolithiasis
1%
Transcatheter arterial chemoembolisation
1%
Varicose vein
1%
Depression
1%
Angina pectoris
1%
Angina unstable
1%
Arrhythmia
1%
Cardiac failure congestive
1%
Coronary artery stenosis
1%
Stress cardiomyopathy
1%
Ear infection
1%
Endophthalmitis
1%
Septic shock
1%
Femoral neck fracture
1%
Hip fracture
1%
Traumatic haemothorax
1%
Exostosis
1%
Adenocarcinoma gastric
1%
Prostate cancer
1%
Cystocele
1%
Acute pulmonary oedema
1%
Erythema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Aflibercept + Sham PDT
Aflibercept + Active PDT
Aflibercept (Non-randomized)
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: VisudyneExperimental Treatment1 Intervention
Visudyne half fluence- 1 treatment with the possibility of a second treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Verteporfin
FDA approved
Find a Location
Who is running the clinical trial?
Manhattan Eye, Ear & Throat HospitalLead Sponsor
16 Previous Clinical Trials
165 Total Patients Enrolled
Lawrence A. Yannuzzi, M.D.Principal InvestigatorNorthshore LIJ/MEETH
1 Previous Clinical Trials