Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT04334499 |
| Other study ID # |
19-0291 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 21, 2020 |
| Est. completion date |
December 7, 2022 |
Study information
| Verified date |
March 2023 |
| Source |
The University of Texas Medical Branch, Galveston |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This study is to characterize mitochondrial DNA (mtDNA) populations in adults with eye
injuries and eye diseases. The eye exam is often hindered by the clouding of tissues involved
in injury or disease. This protocol examines the use of mtDNA populations as indicators of
developing inflammation and resolution of injury. This may be used to provide proactive
treatment or define appropriate treatment needs beyond the indications of an ophthalmological
exam.
Description:
The study aim to test correlation between the presence of the mitochondrial DNA in vitreous
fluid and blood in patients that are admitted to UTMB's Eye clinic. The goal of the study is
to analyze 4 groups of 30 samples of each major ocular disease and injury: age-related
macular degeneration, glaucoma and diabetic retinopathy and ocular trauma. Up to 300 subjects
may be consented to this study in order to meet recruitment goals. In this study we will use
only otherwise discarded eye's vitreous together with a blood sample that is collected during
surgery. Patients with ophthalmic surgery scheduled that may result in discarded vitreal
fluid will be identified from the clinic schedule or by physician in the emergency room. The
possibility of vitreous collection in a surgery may be uncertain. If a subject does not have
discarded vitreous from a given surgery they will be screen failed prior to blood draw or
data collection from electronic medical record from that moment forward. Subjects will be
approached when appropriate for interest in participation in the study by their clinical
faculty surgeon. An informed consent briefing will be provided by the clinical research
coordinator with an opportunity to ask questions of both the coordinator, the clinical
faculty surgeon and the principle investigator. Copies of the consent will be provided for
the patient to take home. Additional opportunity for questions the morning of surgery will be
provided. Consent signature will be obtained prior to any medication administration the upon
admission for surgery. Samples if available will be collected during the eye surgery. Up to
1ml of vitreous fluid and up to 10 ml of blood will be collected from each patient. Samples
will be stored at room temperature and transferred directly to Dr. Szczesny's laboratory.
Vitreous fluid will be frozen for further analysis and blood plasma will be processed using
histopaque and centrifugation prior freezing. Two types of analysis will be conducted with
collected biospecimens.1) Total DNA will be isolated, follow by analysis with real-time
quantitative polymerase chain reaction (RTq-PCR) using set of primers to identify the
presence of the mitochondrial DNA and nuclear DNA as a control. 2) Extracellular vesicles
will be isolated using ultracentrifugation or commercially available kit followed by analysis
of the mitochondrial and nuclear DNA and/or plasma membrane markers using RTq-PCR and/or
Western blot. Electronic medical records will be accessed to collect demographics and
ophthalmologic diagnostic information and information on other comorbidity diagnoses.
These data points will include age in years, gender, race, ethnicity, presence of age related
macular degeneration(AMD) (y/n), type and stage of AMD, use of AREDs vitamins, treatments of
AMD, Glaucoma(y/n), type and stage of glaucoma, diabetes, blood glucose, diabetic retinopathy
(y/n), type and stage of diabetic retinopathy, treatments of diabetic retinopathy and amount
of time prior to this planned surgery, hypertension type and stage, renal disease type and
stage, smoking history, cancer, cancer type, treatment or surgery, viral diagnoses (HIV, CMV,
HCV), blunt eye trauma history, cataract history, lens removal surgery, cause of vitrectomy,
concomitant medications and procedures, eye exam observations relevant to inflammatory
processes, Optical coherence tomography data. IOP, visual field [VF] data, visual acuity,
gonioscopic findings,.
