Exudative Age Related Macular DegenerationPhase 4NCT04075136
Optical Coherence Tomography Angiography (OCTA) - Directed PDT Triple Therapy
A Phase 4 study testing Ranibizumab, Photodynamic laser treatment (PDT) and Triamcinolone Acetonide in people with Exudative Age Related Macular Degeneration, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Optical Coherent Tomography Angiography (OCTA)-Directed PDT Triple Therapy for Treatment-Naïve Patients with Exudative Age-related Macular Degeneration (ARMD) versus Standard of Care Anti-VEGF Monotherapy Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Exudative Age Related Macular Degeneration
- What is being tested?
- Ranibizumab, Photodynamic laser treatment (PDT) and Triamcinolone Acetonide
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2023to Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to give written informed consent
- Willing and able to comply with all study procedures for the duration of the study.
- Presence of Exudative ARMD with evidence of choroidal neovascularization: type 1, 2, and/or 3 on spectral domain OCT, fluorescein angiography, indocyanine green angiogram and optical coherent tomography angiography
- Visual Acuity of 20/25 to 20/400 at screening and baseline visits using an autorefractor or Early Treatment Diabetic Retinopathy Study
- Intraocular pressure less than or equal to 25mmHG
- Females of childbearing potential that are willing to use medically acceptable methods of birth control.
Who cannot join
- Exudation maculopathies without drusen
- Previous treatment with macular photocoagulation, anti-VEGF medication or PDT with Visudyne
- Myocardial infarction or cerebrovascular accident within the last 6 weeks
- Previous vitrectomy
- Optic neuropathy
- Diabetic retinopathy
Show all 10Show fewer
- Traction maculopathies
- Allergies to fluorescein and indocyanine, dilating agents or anti-VEGF medications
- Have received previous treatment for ARMD
- Any uncontrolled condition or illness that in the opinion of the investigator makes the subject unsuitable for the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: OCTA-Directed PDT Triple Therapy for Treatment-Naïve Patients With Exudative Age-Related Macular Degeneration Versus Standard of Care Anti-VEGF(Anti-vascular Endothelial Growth Factor) Monotherapy
Optical Coherent Tomography Angiography (OCTA)-Directed PDT Triple Therapy for Treatment-Naïve Patients with Exudative Age-related Macular Degeneration (ARMD) versus Standard of Care Anti-VEGF Monotherapy
Read the detailed description
This study is a 48 week, single center, randomized controlled clinical trial. Approximately 150 subjects will be randomized into three separate arms. This study compares the efficacy of standard of care Lucentis (ranibizumab) monotherapy versus OCTA-Directed PDT Triple Therapy with Lucentis (ranibizumab), PDT with Visudyne (verteporfin), and Triescence (triamcinolone acetonide) in treatment-naïve patients with Exudative Age-Related Macular Degeneration. OCTA-Directed PDT Double Therapy with Lucentis (ranibizumab) and PDT with Visudyne (verteporfin) will also be tested to confirm the hypothesis that steroids are necessary.
- Being tested
- Ranibizumab, Photodynamic laser treatment (PDT), Triamcinolone Acetonide, verteporfin
- Keywords
- Macular degeneration, Lucentis, Triescense, Photodynamic laser treatment
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Also called Lucentis
Intravitreal injection 0.5 MG Per 0.05 ML Injection.
Photodynamic laser treatment (PDT)Device
PDT light dose of 50 J/cm2 of neovascular lesion administered at an intensity of 600mW/cm2. A Visudyne infusion will be administered for the PDT portion of the treatment at a dose of 6mg/m2 body surface area. PDT will be administered at half-fluence - measured by time, i.e. 42 seconds as opposed to full-fluence which is 83 seconds.
Triamcinolone AcetonideDrug
Also called Triesence
Intravitreal injection of 0.5ml-2mg
verteporfinDrug
Also called Visudyne
Visudyne infusion will be administered for the PDT portion of the treatment at a dose of 6mg/m2 body surface area.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Lucentis | Active comparator | A standard of care treatment of 0.05ml/0.5mg Lucentis given every 4 weeks for 48 weeks. Receives: Drug: Ranibizumab |
| Arm B: Lucentis & PDT Laser | Experimental | A one time treatment of 0.05ml/0.5mg Lucentis in combination with PDT laser administered at half-fluence. Receives: Drug: Ranibizumab; Device: Photodynamic laser treatment (PDT); Drug: verteporfin |
| Arm C: Lucentis, PDT Laser and Triescense | Experimental | A one time treatment of 0.05ml/0.5mg Lucentis in combination with PDT laser administered at half-fluence and an intravitreal injection of 0.5ml-2mg Triescence at the time of PDT treatment. Receives: Drug: Ranibizumab; Device: Photodynamic laser treatment (PDT); Drug: Triamcinolone Acetonide; Drug: verteporfin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subretinal exudation resolution
The percentage of subretinal exudation resolution
Measured: 6 months
Percentage of intraretinal exudation resolution
The percentage of intraretinal exudation resolution
Measured: 6 months
Secondary outcomes (7)
Percentage of subretinal exudation resolution
Subretinal exudation resolution
Measured: 12 months
Percentage of intraretinal exudation resolution
Intraretinal exudation resolution
Measured: 12 months
Best corrected visual acuity (BCVA)
Best corrected visual acuity
Measured: Baseline
Best corrected visual acuity (BCVA)
Best corrected visual acuity
Measured: 12 months
Duration of treatment effect
Duration of treatment effect
Measured: Up to 6 months
Foveal thickness
Measured using Optical coherence tomography (OCT)
Measured: Baseline
Foveal thickness
Measured using Optical coherence tomography (OCT)
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start30 Mar 2023
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: IRB stopped study due to safety concerns before any participants were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exudative Age Related Macular DegenerationStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Modulight
- Responsible party
- Sponsor
- Investigators
- Mark Nelson, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04075136
- Sponsor's protocol ID
- IRB00058375
- Status last verified
- Apr 2023
- First submitted
- 29 Aug 2019
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: Results will updated once final analysis is complete.
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OCTA-Directed PDT Triple Therapy for Treatment-Naïve Patients With Exudative Age-Related Macular Degeneration Versus Standard of Care Anti-VEGF(Anti-vascular Endothelial Growth Factor) Monotherapy
- ClinicalTrials.gov ID
- NCT04075136
- Acronym / sponsor ID
- IRB00058375
- Keywords
- Macular degeneration, Lucentis, Triescense, Photodynamic laser treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: IRB stopped study due to safety concerns before any participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Modulight
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 30 Aug 2019 (actual)
- 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.
Optical Coherent Tomography Angiography (OCTA)-Directed PDT Triple Therapy for Treatment-Naïve Patients with Exudative Age-related Macular Degeneration (ARMD) versus Standard of Care Anti-VEGF Monotherapy
Detailed description
This study is a 48 week, single center, randomized controlled clinical trial. Approximately 150 subjects will be randomized into three separate arms. This study compares the efficacy of standard of care Lucentis (ranibizumab) monotherapy versus OCTA-Directed PDT Triple Therapy with Lucentis (ranibizumab), PDT with Visudyne (verteporfin), and Triescence (triamcinolone acetonide) in treatment-naïve patients with Exudative Age-Related Macular Degeneration. OCTA-Directed PDT Double Therapy with Lucentis (ranibizumab) and PDT with Visudyne (verteporfin) will also be tested to confirm the hypothesis that steroids are necessary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: Lucentis | Active comparator | Drug: RanibizumabA standard of care treatment of 0.05ml/0.5mg Lucentis given every 4 weeks for 48 weeks. |
| Arm B: Lucentis & PDT Laser | Experimental | Drug: Ranibizumab, Device: Photodynamic laser treatment (PDT), Drug: verteporfinA one time treatment of 0.05ml/0.5mg Lucentis in combination with PDT laser administered at half-fluence. |
| Arm C: Lucentis, PDT Laser and Triescense | Experimental | Drug: Ranibizumab, Device: Photodynamic laser treatment (PDT), Drug: Triamcinolone Acetonide, Drug: verteporfinA one time treatment of 0.05ml/0.5mg Lucentis in combination with PDT laser administered at half-fluence and an intravitreal injection of 0.5ml-2mg Triescence at the time of PDT treatment. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Willing to give written informed consent
- Willing and able to comply with all study procedures for the duration of the study.
- Presence of Exudative ARMD with evidence of choroidal neovascularization: type 1, 2, and/or 3 on spectral domain OCT, fluorescein angiography, indocyanine green angiogram and optical coherent tomography angiography
- Visual Acuity of 20/25 to 20/400 at screening and baseline visits using an autorefractor or Early Treatment Diabetic Retinopathy Study
- Intraocular pressure less than or equal to 25mmHG
Key exclusion criteria (10 listed)
- Exudation maculopathies without drusen
- Previous treatment with macular photocoagulation, anti-VEGF medication or PDT with Visudyne
- Myocardial infarction or cerebrovascular accident within the last 6 weeks
- Previous vitrectomy
- Optic neuropathy
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 |
|---|---|---|
| RanibizumabAlso: LucentisIntravitreal injection 0.5 MG Per 0.05 ML Injection. | Drug | Arm A: Lucentis, Arm B: Lucentis & PDT Laser, Arm C: Lucentis, PDT Laser and Triescense |
| Photodynamic laser treatment (PDT)PDT light dose of 50 J/cm2 of neovascular lesion administered at an intensity of 600mW/cm2. A Visudyne infusion will be administered for the PDT portion of the treatment at a dose of 6mg/m2 body surface area. PDT will be administered at half-fluence - measured by time, i.e. 42 seconds as opposed to full-fluence which is 83 seconds. | Device | Arm B: Lucentis & PDT Laser, Arm C: Lucentis, PDT Laser and Triescense |
| Triamcinolone AcetonideAlso: TriesenceIntravitreal injection of 0.5ml-2mg | Drug | Arm C: Lucentis, PDT Laser and Triescense |
| verteporfinAlso: VisudyneVisudyne infusion will be administered for the PDT portion of the treatment at a dose of 6mg/m2 body surface area. | Drug | Arm B: Lucentis & PDT Laser, Arm C: Lucentis, PDT Laser and Triescense |
Primary outcome
Percentage of subretinal exudation resolution
Time frame: 6 months
The percentage of subretinal exudation resolution
Percentage of intraretinal exudation resolution
Time frame: 6 months
The percentage of intraretinal exudation resolution
7 secondary outcomes
Percentage of subretinal exudation resolution
Time frame: 12 months
Percentage of intraretinal exudation resolution
Time frame: 12 months
Best corrected visual acuity (BCVA)
Time frame: Baseline
Best corrected visual acuity (BCVA)
Time frame: 12 months
Duration of treatment effect
Time frame: Up to 6 months
Foveal thickness
Time frame: Baseline
Foveal thickness
Time frame: 12 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: No. Results will updated once final analysis is complete.
Related trials for Exudative Age Related Macular Degeneration
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Neovascular Age-related Macular Degeneration
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A Study of the Efficacy, Safety, and Pharmacokinetics of a 36-Week Refill Regimen for the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration (Velodrome)
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Extension Study for the Port Delivery System With Ranibizumab (Portal)
Neovascular Age-Related Macular Degeneration
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Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
Neovascular Age-related Macular Degeneration
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A Study to Determine the Efficacy, Safety, and Durability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration
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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. This study is not recruiting at the moment.
Mark Nelson, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ranibizumab, Photodynamic laser treatment (PDT) and Triamcinolone Acetonide in people with Exudative Age Related Macular Degeneration, run by Wake Forest University Health Sciences 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 6 inclusion and 10 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: withdrawn, as of the sponsor's last update on 22 Mar 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subretinal exudation resolution (time frame: 6 months). The study lists 2 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 22 Mar 2024.