Inflammation Clinical Trial
Official title:
A Pilot Study of a Sustained-Release Cyclosporine A Implant for Uveitis
This study will evaluate the safety and effectiveness of a sustained-release cyclosporin
implant to treat uveitis, a sight-threatening eye inflammation caused by an immune system
abnormality. Previous studies in humans have shown that, taken by mouth, the drug
cyclosporin is effective in treating chronic uveitis.
Uveitis may require long-term treatment with potent immune-suppressing drugs, such as
cyclosporin, cyclophosphamide, methotrexate, azathioprine or steroids. Taken systemically
(by mouth or injection), however, these drugs can do serious damage to the kidneys, liver or
lungs, and can raise blood pressure and lower blood cell counts. Because of this, some
patients cannot or will not use these medicines.
This small pilot study will evaluate the safety, and to some extent effectiveness, of
cyclosporin delivered directly into the eye, to try to prevent harmful side effects. In
animal studies, sustained-release cyclosporin implants did not cause the severe side effects
seen with systemic use of the drug. Some animals developed opacity of the lens and slowed
retinal responses, both of which reversed when the drug was stopped. Earlier animal studies
of cyclosporin injected directly into the eye reduced inflammation that had been produced
experimentally.
Patients with uveitis who have active inflammation and poor vision are eligible to
participate in this study. Patients will be randomly assigned to one of two treatment
groups. One group will receive a 1-mg implant that releases 0.8 micrograms of drug each day;
the second group will receive a 2-mg implant that delivers 1.4 micrograms of drug a day.
Before surgery, patients will have a medical history, basic physical examination, and
complete eye examination, including special tests called electroretinogram and fluorescein
angiography. An electroretinogram measures the electrical responses generated in the retina
in the back of the eye. Fluorescein angiography uses a special camera to photograph the
retina, showing the condition of the blood vessels in the eye.
The surgical procedure to place the implant takes about 1.5 hours and may be done under
either local or general anesthesia. Patients will stay in the hospital overnight. After
discharge from the hospital, they will return for follow-up visits 1 and 2 weeks after
surgery, then once a month for 6 months, and then every 3 months until the implant is
depleted of drug or removed. During these follow-up visits, eye examinations will be
repeated to evaluate the effects of the implant on the eye. Repeat blood tests will measure
the amount of cyclosporin in the blood and the drug's effect on the kidneys. When the
implant runs out of drug (between 2 and 3 years), it may be removed or left in place.
Sight threatening uveitis may require long term use of systemic immunosuppressants. In some patients, aggressive systemic immunosuppressive therapy fails to control inflammation and can lead to serious side effects. Oral Cyclosporin A (CsA) has been shown in several human trials to be effective in treating chronic uveitis. This pilot study will assess the safety, and to some extent efficacy, of a novel intraocular CsA release implant in patients with active inflammation and poor visual acuity in one eye despite immunosuppressant therapy. Patients will be randomly assigned to receive in one eye a 1 or 2 mg CsA implant releasing at either 0.8 microgram per day or 1.4 microgram per day respectively. The main purpose of the study is to assess the safety of the CsA implant. Secondary outcomes will include a change from baseline in the ocular inflammation, visual acuity, and the need for concomitant anti-inflammatory medications. ;
Endpoint Classification: Safety Study, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03995979 -
Inflammation and Protein Restriction
|
N/A | |
Completed |
NCT03255187 -
Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Completed |
NCT03577223 -
Egg Effects on the Immunomodulatory Properties of HDL
|
N/A | |
Completed |
NCT04383561 -
Relationship Between LRG and Periodontal Disease
|
N/A | |
Active, not recruiting |
NCT03622632 -
Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
|
||
Completed |
NCT06216015 -
Exercise Training and Kidney Transplantation
|
N/A | |
Completed |
NCT04856748 -
Nomogram to Diagnose Prostatic Inflammation (PIN) in Men With Lower Urinary Tract Symptoms
|
||
Completed |
NCT05529693 -
Efficacy of a Probiotic Strain on Level of Markers of Inflammation in an Elderly Population
|
N/A | |
Recruiting |
NCT05670301 -
Flemish Joint Effort for Biomarker pRofiling in Inflammatory Systemic Diseases
|
N/A | |
Recruiting |
NCT05415397 -
Treating Immuno-metabolic Depression With Anti-inflammatory Drugs
|
Phase 3 | |
Recruiting |
NCT04543877 -
WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study
|
Early Phase 1 | |
Recruiting |
NCT05775731 -
Markers of Inflammation and of the Pro-thrombotic State in Hospital Shift and Day Workers
|
||
Completed |
NCT03859934 -
Metabolic Effects of Melatonin Treatment
|
Phase 1 | |
Completed |
NCT03429920 -
Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors
|
N/A | |
Completed |
NCT06065241 -
Quantifiably Determine if the Botanical Formulation, LLP-01, Has a Significant Clinical Effect on Proteomic Inflammatory Biomarkers and Epigenetic Changes in Healthy, Older Individuals.
|
N/A | |
Completed |
NCT05864352 -
The Role of Dietary Titanium Dioxide on the Human Gut Microbiome and Health
|
||
Completed |
NCT03318731 -
Efficacy and Safety of Fenugreek Extract on Markers of Muscle Damage and Inflammation in Untrained Males
|
N/A | |
Not yet recruiting |
NCT06134076 -
Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota
|
N/A | |
Not yet recruiting |
NCT06422494 -
The Role of the Adrenergic System in Hypoglycaemia Induced Inflammatory Response in People With Type 1 Diabetes and People Without Type 1 Diabetes-RAID-II
|
N/A |