Neovascular (Wet) Age-related Macular Degeneration (AMD)NCT02253030
OCT Angiography in Wet AMD
An observational study of Neovascular (Wet) Age-related Macular Degeneration (AMD), run by Oregon Health and Science University at 1 site in United States.
Trial summary
The primary goals of this study are to use optical coherence tomography (OCT) angiography (blood vessel mapping) to: 1. diagnose the presence of new blood vessels in wet age-related macular degeneration (AMD) 2. evaluate patients undergoing treatment for wet AMD 3. Read more about this study
- Who is it for?
- Ages 50 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Neovascular (Wet) Age-related Macular Degeneration (AMD)
- What is being tested?
- Optical Coherence Tomography
- Type of treatment
- Medical device
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Both female and male participants over the age of 50 are being studied.
Who may be able to join
- Adults aged 50 and older with clinical findings of treatment-naïve (never treated) neovascular AMD with active new blood vessel growth confirmed by clinical testing will be considered
- No evidence of retinal disease
- Refractive error greater than +3.00 diopters or -7.00 diopters (glasses Rx)
- No recent eye surgery in the last 4 months
- No significant cataract to interfere with the quality of the imaging
Who cannot join
- Inability to give informed consent
- Significant kidney disease
- Blood pressure greater than 180/110
- Previous macular laser treatment
- Inability to maintain stable fixation during OCT imaging
- Visual acuity worse than 20/200
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Casey Eye Institute, Oregon Health & Science University
Portland, Oregon, 97239
George Pacheco, COA, 503-494-7398, pachecge@ohsu.edu
Denny Romfh, OD, 503-494-4351, romfhd@ohsu.edu
About this study
Official title: Optical Coherence Tomography Angiography in Neovascular Age-related Macular Degeneration
The primary goals of this study are to use optical coherence tomography (OCT) angiography (blood vessel mapping) to:
- diagnose the presence of new blood vessels in wet age-related macular degeneration (AMD)
- evaluate patients undergoing treatment for wet AMD
- determine if reduced flow to the choroid is a risk factor for developing wet AMD.
- Being tested
- Optical Coherence Tomography
- Keywords
- AMD, OCT, Angiography, Macular degeneration
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence TomographyDevice
| Study group | Role | What they receive |
|---|---|---|
| Newly-diagnosed, untreated wet AMD | This group will be adults newly diagnosed with wet AMD who have not undergone any treatment for the condition. Their data will be gathered only once, prior to treatment. Receives: Device: Optical Coherence Tomography | |
| Wet AMD undergoing "as-needed" treatment | This group will be adults undergoing treatment as-needed for wet AMD. They will be followed monthly over the course of 1 year. Receives: Device: Optical Coherence Tomography | |
| High-risk eyes | This group will be adults with wet AMD in one eye and findings of dry AMD in the other. The eye with dry AMD will be followed every 6 months for 3 years. Receives: Device: Optical Coherence Tomography | |
| Wet AMD undergoing a "treat and extend" strategy | This group will be adults with wet AMD undergoing treatment under the "treat and extend" strategy. (The "treat and extend" strategy increases the intervals between treatments as long as the macula remains dry.) They will be followed over the course of 1 year with extra imaging before extending follow-up intervals. Receives: Device: Optical Coherence Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of choroidal neovascular (CNV) vessel area in mm2
Measured: 1 year
Measure of CNV membrane area in mm2
Measured: 1 year
Measure of CNV length density in mm
Measured: 1 year
Measure of retinal fluid volume in mm3
Measured: 1 year
Measure of drusen area in mm2
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular (Wet) Age-related Macular Degeneration (AMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Huang, Oregon Health and Science University
- Investigators
- Steven Bailey, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02253030
- Sponsor's protocol ID
- IRB#000010535
- Status last verified
- Feb 2024
- First submitted
- 25 Sep 2014
- Last updated
- 12 Feb 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography Angiography in Neovascular Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT02253030
- Acronym / sponsor ID
- IRB#000010535
- Keywords
- AMD, OCT, Angiography, Macular degeneration
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary goals of this study are to use optical coherence tomography (OCT) angiography (blood vessel mapping) to:
- diagnose the presence of new blood vessels in wet age-related macular degeneration (AMD)
- evaluate patients undergoing treatment for wet AMD
- determine if reduced flow to the choroid is a risk factor for developing wet AMD.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Newly-diagnosed, untreated wet AMD | – | Device: Optical Coherence TomographyThis group will be adults newly diagnosed with wet AMD who have not undergone any treatment for the condition. Their data will be gathered only once, prior to treatment. |
| Wet AMD undergoing "as-needed" treatment | – | Device: Optical Coherence TomographyThis group will be adults undergoing treatment as-needed for wet AMD. They will be followed monthly over the course of 1 year. |
| High-risk eyes | – | Device: Optical Coherence TomographyThis group will be adults with wet AMD in one eye and findings of dry AMD in the other. The eye with dry AMD will be followed every 6 months for 3 years. |
| Wet AMD undergoing a "treat and extend" strategy | – | Device: Optical Coherence TomographyThis group will be adults with wet AMD undergoing treatment under the "treat and extend" strategy. (The "treat and extend" strategy increases the intervals between treatments as long as the macula remains dry.) They will be followed over the course of 1 year with extra imaging before extending follow-up intervals. |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Both female and male participants over the age of 50 are being studied.
Key inclusion criteria (5 listed)
- Adults aged 50 and older with clinical findings of treatment-naïve (never treated) neovascular AMD with active new blood vessel growth confirmed by clinical testing will be considered
- No evidence of retinal disease
- Refractive error greater than +3.00 diopters or -7.00 diopters (glasses Rx)
- No recent eye surgery in the last 4 months
- No significant cataract to interfere with the quality of the imaging
Key exclusion criteria (6 listed)
- Inability to give informed consent
- Significant kidney disease
- Blood pressure greater than 180/110
- Previous macular laser treatment
- Inability to maintain stable fixation during OCT imaging
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical Coherence Tomography | Device | High-risk eyes, Newly-diagnosed, untreated wet AMD, Wet AMD undergoing "as-needed" treatment, Wet AMD undergoing a "treat and extend" strategy |
Primary outcome
Measure of choroidal neovascular (CNV) vessel area in mm2
Time frame: 1 year
Measure of CNV membrane area in mm2
Time frame: 1 year
Measure of CNV length density in mm
Time frame: 1 year
Measure of retinal fluid volume in mm3
Time frame: 1 year
Measure of drusen area in mm2
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
Related trials for Neovascular (Wet) Age-related Macular Degeneration (AMD)
Active, not recruitingPhase 3
4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration
Macular Neovascularization Secondary to Age-Related Macular Degeneration
RecruitingPhase 3
Single Intravitreal (IVT) Injection of 4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration
Neovascular Age-Related Macular Degeneration (nAMD)
RecruitingPhase 1/2
Phase 1b/2a Study of EYC-0305 in Patients With Neovascular Age-related Macular Degeneration
Neovascular (Wet) Age-Related Macular Degeneration
RecruitingPhase 2/3
A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002)
Macular Degeneration, Age-Related Macular Degeneration
Not yet recruitingObservational study
MIND-AMD Study: a Multidisciplinary Investigation of Neuroretinal Damage in Age-related Macular Degeneration.
Age-Related (Dry) Macular Degeneration, Age-Related Macular Degeneration (AMD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Steven Bailey, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neovascular (Wet) Age-related Macular Degeneration (AMD), run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact George Pacheco, COA (503-494-7398, pachecge@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of choroidal neovascular (CNV) vessel area in mm2 (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.