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Mitochondrial DNA in Vitreous Fluid and Blood in Patients With Eye Disease or Ocular Trauma.

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ClinicalTrials.gov Identifier: NCT04334499
Recruitment Status : Not yet recruiting
First Posted : April 6, 2020
Last Update Posted : April 6, 2020
Sponsor:
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

Brief 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.

Condition or disease Intervention/treatment
Eye Diseases Ophthalmic Trauma Mitochondrial DNA Age Related Macular Degeneration Glaucoma Diabetic Retinopathy Other: Sample collection from tissue discard

Detailed 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,.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigation of the Relationship Between Mitochondrial DNA in Vitreous Fluid and Blood in Patients With Eye Disease or Ocular Trauma.
Estimated Study Start Date : August 21, 2020
Estimated Primary Completion Date : January 26, 2022
Estimated Study Completion Date : February 26, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Age Related Macular Degeneration
Subjects with Age Related Macular Degeneration upon evaluation for ocular surgery that may involve the discard of vitreous humor tissue.
Other: Sample collection from tissue discard
Collection of vitreous humor tissue and venous blood from subjects undergoing ocular surgery that may provide vitreous humor discarded tissue.

Glaucoma
Subjects with Glaucoma upon evaluation for ocular surgery that may involve the discard of vitreous humor tissue.
Other: Sample collection from tissue discard
Collection of vitreous humor tissue and venous blood from subjects undergoing ocular surgery that may provide vitreous humor discarded tissue.

Diabetic Retinopathy
Subjects with Diabetic Retinopathy upon evaluation for ocular surgery that may involve the discard of vitreous humor tissue.
Other: Sample collection from tissue discard
Collection of vitreous humor tissue and venous blood from subjects undergoing ocular surgery that may provide vitreous humor discarded tissue.

Ocular Trauma
Subjects with Ocular Trauma upon evaluation for ocular surgery that may involve the discard of vitreous humor tissue.
Other: Sample collection from tissue discard
Collection of vitreous humor tissue and venous blood from subjects undergoing ocular surgery that may provide vitreous humor discarded tissue.

Control
Subjects with no ocular disease or trauma comorbidities upon evaluation for ocular surgery that may involve the discard of vitreous humor tissue.
Other: Sample collection from tissue discard
Collection of vitreous humor tissue and venous blood from subjects undergoing ocular surgery that may provide vitreous humor discarded tissue.




Primary Outcome Measures :
  1. Quantitation of mitochondrial DNA in vitreous humor and serum samples [ Time Frame: 1 day ]
    mtDNA quantitation by RTq-PCR


Secondary Outcome Measures :
  1. Evaluation of mtDNA quantitation versus ocular comorbities as described in electronic medical record. [ Time Frame: 1 month ]
    Collection of comorbidity data from electronic medical record and comparison with quantiative analysis of mtDNA.


Biospecimen Retention:   Samples With DNA

Samples of vitreous humor and plasma will be collected for analysis of mtDNA by RTq-PCR.

Remaining samples will be maintained in a de-identified state for unidentified future research without additional consent.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects suffering eye disease or ocular trauma and healthy subjects undergoing ocular surgery which may include the discard of vitreous humor.
Criteria

Inclusion Criteria:

  • a) Target group

    1. Age ≥ 20 years old
    2. Subjects must not be nursing, pregnant or planning to become pregnant. Subjects of child bearing potential must have a documented negative pregnancy test at the time of preoperative assessment or not be of child bearing potential. dentified eye disease including but not limited to age-related macular degeneration, glaucoma and/or diabetic retinopathy.
    3. Scheduled ophthalmic surgery with expected vitreal humor discard.
    4. Subject has provided written informed consent to participate in this protocol. b) Control group
    1. Age ≥ 20 years old
    2. Subjects must not be nursing, pregnant or planning to become pregnant. Subjects of child bearing potential must have a documented negative pregnancy test at the time of preoperative assessment or not be of child bearing potential.
    3. Lack of identified eye disease.
    4. Scheduled ophthalmic surgery with expected vitreal humor discard.
    5. Subject has provided written informed consent to participate in this protocol.

Exclusion Criteria:

  • a) Target group

    1. Age < 20 years old
    2. Subject is nursing, pregnant, planning to become pregnant or of child bearing potential and does not agree to the use of reliable method of contraception during their participation in the study. A pregnancy test must be administered to women of childbearing potential at the time of preoperative assessment.
    3. Identified eye disease including but not limited to age-related macular degeneration, glaucoma and/or diabetic retinopathy.
    4. Subject has not completed informed consent to participate in this protocol. b) Scheduled ophthalmic surgery with expected vitreal humor discard Control group
    1. Age < 20 years old
    2. Subject is nursing, pregnant, planning to become pregnant or of child bearing potential and does not agree to the use of reliable method of contraception during their participation in the study. A pregnancy test must be administered to women of childbearing potential at the time of preoperative assessment.
    3. Lack of identified eye disease.
    4. Subject has not completed informed consent to participate in this protocol. Scheduled ophthalmic surgery with expected vitreal humor discard.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04334499


Contacts
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Contact: Mary Schmitz-Brown, B.S. CCRC 409-747-5843 meschmit@utmb.edu
Contact: Gianmarco Vizzeri, M.D. 409-747-5843 givizzer@utmb.edu

Locations
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United States, Texas
University of Texas Medical Branch, Ophthalmology Clinical Research Center
Galveston, Texas, United States, 77555-1106
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Investigators
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Principal Investigator: Bartosz Szczesny, Ph.D. University of Texas
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Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT04334499    
Other Study ID Numbers: 19-0291
First Posted: April 6, 2020    Key Record Dates
Last Update Posted: April 6, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

Study records will be kept confidential as required by law. Except when required by law, your identifiers will not be disclosed outside of the University of Texas Medical Branch (UTMB). For records disclosed outside of UTMB, you will be assigned a unique code number. The key to this code will be kept in a password protected encrypted format on a limited access server behind the UTMB firewall. It will be destroyed at the end of data collection for this study.

Study samples will also be kept in a de-identified state with the same 4 digit code as the data collection. These samples will be maintained in secured laboratories of the Department of Ophthalmology. The de-identified samples may be maintained past the end of the study for future research without additional consent. Future researchers will have no information on the identity of the subjects.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The University of Texas Medical Branch, Galveston:
mitochondrial DNA
opthalmic trauma
age related macular degeneration
glaucoma
inflammation
inflammatory marker
diabetic retinopathy
Additional relevant MeSH terms:
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Glaucoma
Macular Degeneration
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Wounds and Injuries
Ocular Hypertension
Retinal Degeneration
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases