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NCT Number: NCT05300724

An Observational Study of the Progression of Intermediate Age-Related Macular Degeneration

This is a multicenter prospective study in participants with intermediate age-related macular degeneration (iAMD). One primary objective of this study is to assess iAMD disease progression, by the timeline and rates of conversion for high-risk iAMD at baseline to more advanced atrophic AMD stages. The other primary objective of this observational study is to assess the feasibility of measuring the rate of photoreceptor loss as a potential clinical endpoint. The study will consist of an observation period of approximately 3 years (~144 weeks) for participants.

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Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year–94 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Marsden Eye Specialists, Parramatta, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • For women of childbearing potential, agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, during the study for at least 28 days after the last fluorescein injection for the fluorescein angiography (FA) administration
  • Study eye: High-risk intermediate AMD

Exclusion criteria

  • Macular disease in either eye with subretinal deposits not typical of AMD
  • Pigmentary abnormalities of the retina in either eye not typical of AMD
  • Atrophy in either eye due to causes other than AMD
  • Study eye: Any concurrent or history of ocular or intraocular condition
  • Study eye: Intraocular surgery, including cataract surgery, within 3 months prior to Day 1
  • Study eye: Retinal tears or peripheral retinal breaks within 3 months prior to Day 1
  • Study eye: Concurrent or history of retinal laser photocoagulation or anti-vascular endothelial growth factor (anti-VEGF) treatment for exudative MNV, diabetic macular edema, retinal vein occlusion, or proliferative diabetic retinopathy
  • Study eye: Presence of choroidal nevus with overlying drusen in the circle with a radius 3600 micrometer centered on the fovea
  • Study eye: Previous participation in interventional clinical trials for GA or early stages of AMD, except for vitamins and minerals, regardless of the route of administration within the last 6 months, except for sham-arm participants
  • Study eye: History of glaucoma surgery, corneal transplant, retinal pigment epithelium tear, retinal tear that involves the macula, retinal detachment
  • Either eye: Uncontrolled progressive glaucoma
  • Either eye: Moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy
  • Either eye: History of recurrent infectious or inflammatory ocular disease
  • Any concurrent or history of taking medications that can induce retinal toxicity

Treatment and study plan

No intervention

Other

No intervention will be administered in this study.

Primary outcomes

  1. Rate of Conversion from iAMD to nGA /iRORA

    Time frame: Baseline up to 3 years

  2. Rate of Conversion from nGA/iRORA to cRORA/GA

    Time frame: Baseline up to 3 years

  3. Rate of Photoreceptor Loss as Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT)

    Time frame: Baseline up to 3 years

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

A Multicenter, Prospective, Observational Study of the Progression of Intermediate Age-Related Macular Degeneration

Acronym: HONU

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Mar 29, 2022
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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