Is NCT01432847 recruiting in Bethesda, MD?

Yes, NCT01432847 is currently recruiting participants at its Bethesda, MD location. This retinal disease clinical trial is actively enrolling qualified participants.

How do I join the retinal disease clinical trial in Bethesda?

To join this clinical trial in Bethesda, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Bethesda clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Retinal Disease Clinical Trial in Bethesda, MD

About This Retinal Disease Study in Bethesda

Background: \- Best Vitelliform Dystrophy (Best disease), Late-Onset Retinal Degeneration (L-ORD), and Age-Related Macular Degeneration (AMD) all affect the retina, the light sensing area at the back of the eye. Doctors cannot safely obtain retinal cells to study these diseases. However, cells collected from hair follicles, skin, saliva, urine, and blood can be used for research. Researchers want to collect cells from people with Best disease, L-ORD, and AMD, and compare their cells with those of healthy volunteers. Objectives: \- To collect hair, skin, saliva, urine, and/or blood samples to study three eye diseases that affect the retina: Best disease, L-ORD, and AMD. Eligibility: * Individuals affected with ocular condition is one year of age or older. * Individuals affected with Best disease, L-ORD, or AMD is 18 years of age or older. * Unaffected individuals are seven years of age or older. Design: * The study requires one visit to the National Eye Institute. * Participants will be screened with a medical and eye disease history. They may also have an eye exam. * Participants will provide a hair sample, saliva sample, urine sample, blood sample, and/or a skin biopsy. The hair will be collected from the back of the head, and the skin will be collected from the inside of the upper arm.

Sponsor: National Eye Institute (NEI)

Who Can Participate

Inclusion Criteria

To be eligible, participants must meet the following inclusion criteria.

Have the ability to understand and sign an informed consent or have a parent/legal guardian to do so if they are minor children or have a legally authorized representative if they are adults without consent capacity.

Participant meets one of the following criteria:

Participant has been diagnosed with an ocular condition of interest including but not limited to: degenerative retinal diseases, optic atrophy, microphthalmia/anophthalmia, ciliopathy, and other ocular developmental or degenerative conditions.

Participant is free of eye diseases and could serve as an unaffected control. Participant's age, sex, and ethnicity must match an existing participant with one of the eye diseases under study. Control participants matched to AMD participants must not have drusen greater than 63 microns in size.

Adult participant is able to provide a punch skin biopsy and 30 mL of peripheral venous blood OR child participant is able to provide a punch skin biopsy and the lesser of 5 mL/kg or 30 mL of peripheral venous blood. Healthy, unaffected children will only have one skin punch biopsy done 3mm or less in size. In affected participants, an additional punch may be gathered if the initial sample does not contain adequate cells. This will be taken from children ages seven years and older. Sampling of ten occipital hairs and/or saliva may be pursued at the investigator's discretion. Participants not able to provide a skin biopsy or blood sample may opt to provide 100-200 ml of fresh urine. As a rule, samples will be collected on non-sedated/anesthetized participants. Sedation/anesthesia will NOT be used solely for the purpose of sample collection. In rare instances where a minor requires sedation for another medically indicated procedure, samples may be collected at the time of sedation/anesthesia. Because young children may not be able to cooperate with sample collection, those unable to provide a skin biopsy, urine sample or a blood sample may be excluded from the study, based on the judgment of the examining investigator.

Participant meets one of the following criteria:

Participant affected with an ocular condition is one year of age or older.

Participant affected with Best disease, L-ORD, or AMD is 18 years of age or older.

Unaffected participant is seven years of age or older and willing and able to provide assent.

Exclusion Criteria

A participant is not eligible if any of the following exclusion criteria are present.

Participant is unable to comply with study procedures.

Participant has a systemic disease that, in the opinion of the investigator, compromises the ability to provide adequate samples. Examples of co-existing diseases that would exclude a participant include a bleeding diathesis or a genetic susceptibility to infections, particularly cutaneous infections. ADDITIONAL CRITERIA FOR CLNICAL-GRADE CELL LINE GENERATION: The additional eligibility criteria must be met for participants donating samples for the generation of clinical-grade cell lines. Inclusion Criteria

Participant must be greater than 18 years of age, as of the date of enrollment. There is no upper age limit for donor enrollment.

Participant is able to provide a punch skin biopsy and 200 ml of peripheral venous blood.

Participant is willing and eligible to co-enroll in NEI protocol 15-EI-0128. Exclusion Criteria

Participant has medical history that includes any of the following:

Thrombocytopenia or other blood dyscrasias

Bleeding diathesis

Antibiotic use within the prior 48 hours

Active cancer or history of cancer within the past five years

History of exposure to transfusion transmitted diseases including HIV and hepatitis B and C as defined by the Standards for Blood Banking and Transfusion Services, American Association of Blood Banks.

Travel to an area where malaria is endemic as defined by the CDC (www.cdc.gov/travel)

At risk for the possible transmission of Creuzefeldt-Jackob Disease (CJD) and Variant Creuzefeldt-Jackob Disease (vCJD) as described in the FDA Guidance for Industry, January 9, 2002, "Revised Preventive Measures to Reduce the Possible Risk of Transfusion of Creuzefeldt-Jackob Disease (CJD) and Variant Creuzefeldt-Jackob Disease (vCJD) by Blood and Blood Products"

Participant is currently febrile (temperature \> 38 degrees C)

Participant has Hemoglobin level:

African American women \<11.5 grams/dL

Other women \< 12.0 grams/dL

Men \<12.5 grams/dL

Participant has low hematocrit (HCT):

African American women \< 34%

Other women \<36%

Participant has Platelets \<150 x 103/microL

Participant has Absolute neutrophil count \<1.0 x 103/microL.

Participant has positive tests for blood borne pathogens (as required by the Standards for Blood Banks and Transfusion Services, American Association of Blood Banks. The currently required tests include anti-HIV1/2, anti-HCV, anti-HBc, Anti-HTLV I/II, anti-T. Cruzi, HBsAg, syphilis, and molecular testing for West Nile virus, HCV, HBV, and HIV-1).

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Bethesda?

Yes, this clinical trial (NCT01432847) has an active research site in Bethesda, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Retinal Disease Treatment Options in Bethesda, MD

If you're searching for retinal disease treatment options in Bethesda, MD, this clinical trial (NCT01432847) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Bethesda research site is actively enrolling participants for this clinical trial. You'll receive care from experienced retinal disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all retinal disease clinical trials near you to find additional studies recruiting in your area.

Retinal Disease Clinical Trial in Bethesda, MD

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