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NCT02941263Befejeződött

Natural History of Geographic Atrophy Associated With Age-Related Macular Degeneration

The Natural History of Geographic Atrophy Associated With Age-Related Macular Degeneration

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. aug. 28.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

Background: Age-related macular degeneration (AMD) affects the macula in the eye. This is the central part of the retina. It is needed for sharp, clear vision and activities like reading and driving. AMD is the leading cause of vision loss in Americans 60 years of age and older. An advanced form of AMD is called geographic atrophy or GA. It happens when light-sensitive cells in the macula die so much that central vision decreases. Objective: To learn more about geographic atrophy associated with age-related macular degeneration. Eligibility: Adults at least 55 years old with a certain kind of GA. They must be enrolled in study 08-EI-0102, 08-EI-0169, 08-EI-0043, 12-EI-0042, or 11-EI-0147 but no other studies. Design: Participants will be screened with medical history, physical exam, and an eye exam. Participants will have study visits every 3 months for 15 months, then every 6 months. They will be in the study almost 4 years. Visits will last about 8 hours. At each visit, participants may have: * Medical and eye history. Participants will answer questions about their general health and eye health. They may answer written questions about how their eye problems affect their life. * Eye exam and photographs. Eye pressure will be measured and eye movements will be checked. Pupils will be dilated with drops. The thickness of the retina will be measured and photos of the eye may be taken.

Állapot (regiszter)
Befejeződött
Vizsgálattípus
Megfigyeléses
Résztvevők száma
20 (tényleges)
Első benyújtás
2016. okt. 20.
Kezdés
2017. márc. 8.
Elsődleges befejezés
2024. máj. 22.
Fő szponzor
National Eye Institute (NEI)
NCT-szám
NCT02941263

Mit vállalsz

  • Vizsgálat típusa: Megfigyeléses
  • Bevont résztvevők: 20
  • 2017. márc. 8. és az elsődleges befejezés (2024. máj. 22.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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Korábbi kezelés

  • Participant is actively receiving study therapy in another investigational study.
  • Participant is on ocular or systemic medications known to be toxic to the lens, retina or optic nerve (e.g., ethambutol, chloroquine, or hydroxychloroquine).
    • STUDY EYE ELIGIBILITY CRITERIA:
    • The participant must have at least one eye meeting all inclusion criteria and none of the exclusion criteria listed below.
    • STUDY EYE INCLUSION CRITERIA:
  • Need for ocular surgery during the course of the study.
  • Recent history of lens removal (< 3 months prior to enrollment) or Yttrium Aluminum Garnet (YAG) laser capsulotomy (< 1 month prior to enrollment).

Más betegség

  • Current evidence of neovascularization as determined by the treating physician or a history of treatments for neovascularization.
  • Current evidence or history of ocular disorders in the study eye that might confound study outcome measures, including (but not limited to):
    • non-proliferative diabetic retinopathy involving 10 or more hemorrhages or microaneurysms, or active proliferative diabetic retinopathy
    • Branch or central retinal vein or artery occlusion
    • Macular hole
    • Pathologic myopia
    • Uveitis
    • Pseudovitelliform maculopathy
  • History of vitreoretinal surgery.

Egyéb

  • A participant is not eligible if any of the following exclusion criteria are present.
  • Participant is unable to comply with study procedures or follow-up visits.
  • The study eye(s) must have GA compatible with dry AMD. GA is defined as one or more well-defined and often circular patches of partial or complete depigmentation of the RPE, typically with exposure of underlying choroidal blood vessels. Even if much of the RPE appears to be preserved and large choroidal vessels are not visible, a round patch of RPE partial depigmentation may be classified as early GA. The GA in the study eye must be able to be photographed in their entirety and it must not be contiguous with any areas of peripapillary atrophy, which can complicate area measurements.
  • The study eye(s) must have clarity of ocular media and degree of pupil dilation sufficient to permit adequate fundus photographs.
    • STUDY EYE EXCLUSION CRITERIA:
  • Evidence of retinal atrophy due to causes other than atrophic AMD.

A regiszterben nem jelölt feltételek

  • INCLUSION CRITERIA:
    • To be eligible, the following inclusion criteria must be met, where applicable.
  • Participant must be 55 years of age or older.
  • Participant must understand and sign the protocol s informed consent document.
  • Participant must have evidence of early or intermediate AMD as defined by characteristic presence of drusen and/or pigmentary changes.
  • Participant is enrolled in one of the following screening protocols: 08-EI-0102, 08-EI-0169 (closed), 08-EI-0043, 12-EI-0042, 11-EI-0147, or 16-EI-0134.

Életkor a regiszterben: 55 év – 120 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
National Institutes of Health Clinical CenterBethesdaEgyesült ÁllamokIsmeretlen állapot

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