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Protocol Details

AMD Ryan Initiative Study

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

17-EI-0071

Sponsoring Institute

National Eye Institute (NEI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 55
Max Age: N/A

Referral Letter Required

Yes

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Age Related Macular Degeneration;
Age Related Macular Degeneration (AMD);
Reticular Pseudodrusen;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Age- Related Macular Degeneration

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Eye Institute

Objective:

To learn more about AMD.

Eligibility:

People ages 55 and older with any of the following:

AMD or changes in the retina that put them at risk for AMD

RPD

Healthy eyes

Design:

Participants will be screened with:

Eye exam: The pupil will be dilated with eye drops. Eye pressure and movements will be checked. Pictures will be taken of the inside of the eye.

Reading an eye chart.

Optical coherence tomography (OCT): The eyes are dilated. A machine measures the thickness of the retina.

Participants will have a first visit that includes:

Repeat of screening procedures

Medical history

Physical exam

Questions about vision and general health

Dark adapted fundus perimetry: Participants sit in the dark for 40 minutes. Then they sit at a machine that shines lights in the eyes.

Dark adaption testing: Participants sit in the dark for 45 minutes. The pupils are dilated. They push a button when they see light in a machine for up to 1 hour.

Participants will have annual visits for up to 5 years to repeat the tests in the first visit. Participant data may be shared for other research.

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Eligibility

INCLUSION CRITERIA:

To participate in the longitudinal study, the potential participant must meet all of the following criteria.

-Men and women aged 55 and older;

-Clinical and Reading Center verification:

--Cohort 1 - Early AMD, N=200 (Medium drusen >=63mu and <125mu) OU

--Cohort 2 - RPD, N=200, (2A)At least one eye with RPD with no large drusen (>=125mu) in either eye; (2B)At least one eye with RPD with >=1 large drusen (>=125mu) in either eye (n=100)

--Cohort 3 - Controls, N=100, No medium or large drusen, no peripheral drusen, no RPD or pigmentary changes OU

-Best Corrected Visual Acuity of 20/25 or better;

-Previous ocular surgeries allowed include cataract surgery more than three months prior to enrollment in ARIS and peripheral laser, cryotherapy for peripheral tears;

-Participant must be able to review and understand the informed consent form, agree to the contents and be able to sign the informed consent.

EXCLUSION CRITERIA:

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

-Any evidence of late AMD (i.e. CNV or GA) in either eye.

-Ocular disease other than AMD in either eye, in the Investigator's opinion, which may confound assessment of the retina including:

--Amblyopia (in study eye only for Cohort 2)

---Angioid streaks

---Choroidal nevus within 2 DD of the center of the macula associated with depigmentation or overlying atypical drusen

---Epiretinal membrane of significant size located in the macular area that potentially can cause vision loss

---Myopic crescent of the optic disc the width of which is greater than or equal to 50% of the longest diameter of the disc, or pigmentary abnormalities in the posterior pole considered by the clinic ophthalmologist more likely to be due to myopia than to AMD

--Central Serous Choroidopathy

---Optic Atrophy

---Diabetic retinopathy unless retinopathy is limited to fewer than 10 microaneurysms and/or small retinal hemorrhages

---Macular hole or pseudohole

---Pigmentary abnormalities considered by the Clinical Site ophthalmologist to be less typical of AMD than of some other condition, such as pattern dystrophy or chronic central serous retinopathy

--Retinal vein occlusion, active uveitis, presumed ocular histoplasmosis syndrome, other sight-threatening retinopathies, and other retinal degenerations, significant explained or unexplained visual field loss, or any other type of retinopathy or retinal degeneration

-Previous retinal or other ocular surgical procedures, the effects of which may now or in the future complicate assessment of the progression of AMD in the Investigator s opinion;

--These surgeries can be divided into those for 1) glaucoma: argon laser trabeculoplasty, trabeculectomy, and other penetrating glaucoma surgery involving valves, etc., 2) retinal diseases: laser photocoagulation (except to repair a peripheral retinal hole), cryosurgery (except any procedure to repair a peripheral retinal hole), intravitreal injections, vitrectomy 3) Refractive surgery:

Lasik, peripheral radial keratotomy (PRK), KAMRATM (corneal inlay for correction of presbyopia), 4) corneal diseases: lamellar keratoplasty, penetrating keratoplasty (PKP), Descement Membrane Endothelial Keratoplasty (DMEK), Descemet Stripping Endothelial Keratoplasty (DSEK), DSEK-A (DSEK-automated), Ultra-thin DESK, Deep Anterior lamellar Keratoplasty (DALK),

5) pterygium surgery that affects or threatens the visual axis, Others) radiation for ocular tumor, repair of corneal or sclera laceration.

--Retinal laser treatments and cryosurgery for retinal tears is not an exclusion.

-Any other ocular condition requiring long-term therapy or surgery during the study or any other retinal pathology that in the Investigator s opinion will interfere with the interpretation of the macular AMD findings (e.g., CRVO);

-Participants with confirmed glaucoma (visual field and/or disc/nerve fiber layer defects);

--Participants with a current IOP > 26, a history of the diagnosis of increased intraocular pressure, glaucoma, past or present use of medications to control intraocular pressure, or disc/nerve fiber layer defects suggestive of glaucoma can be eligible if the absence of a glaucomatous visual field defect can be documented by a normal Goldmann, Humphrey or Octopus perimetry test within six months prior to qualification.

-Participant has photographically significant corneal or media opacities;

-Participant has, in the opinion of the Investigator, any physical or mental condition that would increase the risk of participation in the study or may interfere with the study procedures, evaluations and outcome assessments;

-Participant is medically unable to comply with study procedures or follow-up visits.

-Participation in research study involving treatment for AMD.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Emily Y. Chew, M.D.
National Eye Institute (NEI)



Angel H. Garced, R.N.
National Eye Institute (NEI)
National Institutes of Health
Building 10
Room 10D45
10 Center Drive
Bethesda, Maryland 20892
(301) 594-3141
garceda@nei.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT03092492

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