Age Related Macular DegenerationPhase 4NCT03117634
An Open Label-study to Compare the Efficacy of Aflibercept Monotherapy for Polypoidal Choroidal Vasculopathy
A Phase 4 study testing Treat and Extend with Aflibercept 2mg and Fixed Dosing with Aflibercept 2mg in people with Age Related Macular Degeneration and Polypoidal Choroidal Vasculopathy, run by Singapore National Eye Centre at 1 site in Singapore.
Trial summary
Polypoidal choroidal neovasculopathy (PCV) is a subtype of wet age related macula degeneration (AMD) occuring more commonly in the Asian population. Besides the phenotypic differences, PCV is thought to have a lesser response to anti VEGF therapy which is the mainstay of treatment for other typical wet AMD. Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Age Related Macular Degeneration, Polypoidal Choroidal Vasculopathy
- What is being tested?
- Treat and Extend with Aflibercept 2mg and Fixed Dosing with Aflibercept 2mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Dec 2017to 31 Jan 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female study participants, age >=45 years of age at the time of informed consent.
- Best corrected ETDRS visual acuity score <= 78 (ie 20/32 or worse)
- Diagnosis of PCV based on ICGA
- Presence of intra retinal or subretinal fluid/blood at the fovea as seen on OCT
- Treatment naïve
- Media clarity, pupillary dilation and individual cooperation sufficient for study procedure including fundus photography.
Show all 29Show fewer
- Able and willing to provide informed consent.
- 1.2. Exclusion Criteria Participant
- Medical condition that, in the opinion of the investigator, would preclude participation in the study (e.g.unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
- Participation in an investigational trial within 30 days of enrolment which involves treatment with unapproved investigational drug
- Known allergy to any component of the study drug.
- Blood pressure > 180/110 (systolic above 180 OR diastolic above 110 on repeated measurements). If blood pressure is brought below 180/110 by anti-hypertensive treatment, individual can become eligible.
- Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization.
- Systemic anti-VEGF or pro-VEGF treatment within four months prior to randomization or anticipated use during the study.
- Study Eye
- Eye with intra retinal or subretinal fluid due to other causes than PCV
- An ocular condition is present (other than PCV) that, in the opinion of the investigator, might affect intra or sub retinal fluid or alter visual acuity during the course of the study (e.g., diabetic macula edema (DME), vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.)
- Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by more than three lines (i.e., cataract would be reducing acuity to worse than 20/40 if eye was otherwise normal).
- Any intraocular surgery within 3 months of enrollment
- Treatment with intra vitreal corticosteroids
- History of retinal detachment or surgery for retinal detachment
- History of vitrectomy
- History of macular hole
- Evidence of vitreomacular traction that may preclude resolution of macular edema > 4 disc areas of intra/sub retinal hemorrhage
- Aphakia
- Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis
- Other Eye
- Active intraocular inflammation
- History of uveitis
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label-study to Compare the Efficacy of Aflibercept Monotherapy for Polypoidal Choroidal Vasculopathy Using a Modified Intensive Treat and Extend Regime to a Fixed Dosing Regimen
Polypoidal choroidal neovasculopathy (PCV) is a subtype of wet age related macula degeneration (AMD) occuring more commonly in the Asian population. Besides the phenotypic differences, PCV is thought to have a lesser response to anti VEGF therapy which is the mainstay of treatment for other typical wet AMD. Recent trial data suggest that a combination with photodynamic therapy may help in the visual and anatomical outcome of PCV, and emerging evidence shows favourable outcomes the newer anti VEGF agent, aflibercept 2mg monotherapy. These trials however, have assessed aflibercept in a strict 2mg every 8 weekly regime.
In the clinical setting, a significant an unmet need in the management of PCV is a tailored treatment regime. Here we propose a treatment regimen based on disease activity for PCV with aflibercept mono therapy. A limitation of the 2q8 regime is that it is fixed and does not vary regardless of polyp closure or anatomical outcome at the first time point of assessment (month 3). We hypothesize that after the initial 3 monthly injections of aflibercept, about 50% of PCV will close and become quiescent, and in the remaining 50%, a further 3 monthly injections will increase overall polyp closure rate. After a loadings phase of either 3 or 6 months, all eyes will start on a treat and extend regime (T\&E), with a minimum period of 8 weeks and a maximum of 12 weeks between treatments with 2 week increments if PCV remains quiescent. The proposed study aims to evaluate the efficacy of a modified treat and extend regime based on disease activity with aflibercept monotherapy for PCV.
Read the detailed description
Age related macular degeneration (AMD) is one of the leading causes of blindness worldwide. In its exudative or wet form, choroidal neovascularization (CNV) causes an exudative maculopathy resulting in sudden loss of vision with severe effects on patients' quality of life.1,2 Intra vitreal injections of anti-vascular endothelial growth factor agents (anti-VEGF) agents have become the mainstay of treatment for AMD CNV and have been shown to have favorable outcomes in most AMD CNV subtypes.3,4 In the Asian population however, a particular subtype called polypoidal choroidal vasculopathy (PCV), which affects about 50% of exudative maculopathy, has been shown to have less favorable response to anti-VEGF therapy.5,6 The EVEREST trial, a randomized controlled trial which compares the efficacy of photodynamic therapy (PDT) with or without ranibizumab for treatment of PCV showed that PDT with or without anti VEGF improved polyp closure rate on angiographic assessment but this trial did not take into account vision as a primary end point.7 PDT appears work through its effects on choroidal vasculature, hence making it relevant to PCV which is increasingly thought to be a condition on the pachychoroid spectrum.8 PDT however, as a treatment modality presents several disadvantages. Firstly, PCV often presents as a widely distributed lesion, making it difficult to treat, with a single beam of PDT. Secondly, PDT is limited in its ability to treat lesions in the peripapillary area as there is risk of damage to the optic nerve. Thirdly, features commonly associated with PCV such as a large pigment epithelial detachment (PED) or extensive submacular hemorrhages are not usually suitable for PDT. Fourthly, there is a risk of long-term choroidal atrophy especially if repeated treatments are administered.8,9
There is emerging evidence for the use of aflibercept monotherapy in PCV. Reports range from small case series and retrospective studies to larger prospective studies. Recent data from the PLANET study showed that monotherapy of aflibercept resulted in similar letter gains in visual acuity as compared to combination treatment with PDT at 1 year. Polyp closure rate was also similar between the two groups at 38.9% with monotherapy and 44.8% with combination therapy. The VAULT and APOLLO studies suggest vision and anatomical improvements with 66-72% polyp closure in 1 year.10 These trials however, use a fixed dosing regimen (3 monthly loading doses of 2mg aflibercept followed by fixed dosing every 8 weeks (2q8) totaling 7 injections in 1 year). In addition to resolution of subretinal fluid, recent studies using the novel OCT-angiography (OCT-A) to evaluate choroidal vasculature suggests re-modelling of choroidal vasculature may also be an important therapeutic effect. We reported more prominent reduction in choroidal vessel calibre after combination treatment with PDT and bevacizumab compared to bevacizumab monotherapy. The effect of Aflibercept on choroidal vasculature has been less well studied. Some evidence however, suggested aflibercept may have more profound effect on choroidal vasculature with the reducing choroidal thickness than ranibizumab or bevacizumab.
A significant unmet need in the management of PCV with anti VEGF monotherapy is a practical way of treating patients in the real world setting that maximizes efficacy with minimal number of visits and injections. Clinical trial regimes follow a rigid treatment algorithm that aim to maximize response. In the clinical setting, these regimes are impractical in "real world" patients. Regular intensive course of treatment involves lengthy visits which include consultation time, clinical examination, retinal imaging, and often an intra vitreal injection. In clinical practice this often result in treatment fatigue and in a co-payment healthcare environment in Singapore, may also result in significant financial burden to the patient and society.
While aflibercept affords an 8 weekly treatment regime which is better than other monthly anti VEGF therapy regimes, trial regimes still do not take into account individual patients' disease patterns. This study aims to take disease activity into account to tailor treatment regimes specific for patients. In addition, it aims to provide insight into the outcomes of patients on a more clinically relevant treat and extend (T\&E) regime which changes the treatment tempo in relation to disease activity.
- Being tested
- Treat and Extend with Aflibercept 2mg, Fixed Dosing with Aflibercept 2mg
- Keywords
- anti vegf, aflibercept, treat and extend
- Medical subject headings
- Macular Degeneration, Polypoidal Choroidal Vasculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treat and Extend with Aflibercept 2mgDrug
Also called T&E
Drug treatment regime which allows extension of treatment interval based on disease activity
Fixed Dosing with Aflibercept 2mgDrug
Also called 2Q8
Fixed 8 weekly dosing regime throughout the study duration
| Study group | Role | What they receive |
|---|---|---|
| Fixed dosing group (2Q8) | Active comparator | Fixed Dosing with Aflibercept 2mg will be administered at a fixed regime at 8 week intervals through to week 52. Receives: Drug: Fixed Dosing with Aflibercept 2mg |
| Treat and Extend group (T&E) | Experimental | Reassessment at week 12 (month 3) by repeat examination for disease activity by OCT and indocyanine green angiography (ICGA). Subsequent treatment regime of Treat and Extend with Aflibercept 2mg will depend on disease activity at this point. Receives: Drug: Treat and Extend with Aflibercept 2mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Best Corrected Visual Acuity (BCVA)
Mean Change in Best corrected visual acuity (BCVA) from baseline to week 52 for personalized and fixed regimen.
it is a Non-inferiority of personalized to fixed regimen for mean change in BCVA from baseline to week 52 (Non-inferiority is considered as -5 ETDRS Letters difference )
Measured: From Baseline to Week 52
Secondary outcomes (3)
Mean Change in Central Sub Field Thickness
central sub field thickness (CSFT) was defined as the average thickness of the macula in the central 1 mm ETDRS grid. Defined as the thickness from the inner retinal boundary at the location of the inner limiting membrane (ILM) to the outer retinal boundary at Bruch's membrane (BM).
Change in the central sub field thickness (CSFT) after the treatment was assessed , the measurement was done by optical coherence tomography (OCT). the measures were taken at baseline and week 52, the change between the two measurements ( baseline to week 52) were assessed in both groups to understand the effect of treatment on CSFT
Measured: From Baseline to Week 52
Number of Participants With Complete Polypoidal Lesion Closure
This measure reports the Number of participants with complete polypoidal lesion closure defined as those showing no late leakage on Indocyanine green angiography (ICGA).
Measured: At Week 52
Number of Injections
number of aflibercept injections administered in personalised and fixed groups
Measured: From Baseline to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start1 Dec 2017
- Primary completion30 Jun 2020
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Model description
- Prospective, 2-arm, Non-inferiority, interventional study
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore National Eye Centre
- Sponsor type
- Other government
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Gemmy Cheung, Principal investigator, SNEC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117634
- Sponsor's protocol ID
- R1448/31/2017
- Status last verified
- Aug 2021
- First submitted
- 6 Apr 2017
- Last updated
- 18 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Teo KYC, Jordan-Yu JM, Tan ACS, Yeo IYS, Mathur R, Chan CM, Wong TY, Chakravarthy U, Cheung CMG. Efficacy of a novel personalised aflibercept monotherapy regimen based on polypoidal lesion closure in participants with polypoidal choroidal vasculopathy. Br J Ophthalmol. 2022 Jul;106(7):987-993. doi: 10.1136/bjophthalmol-2020-318354. Epub 2021 Feb 11.
PubMed 33574033
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label-study to Compare the Efficacy of Aflibercept Monotherapy for Polypoidal Choroidal Vasculopathy Using a Modified Intensive Treat and Extend Regime to a Fixed Dosing Regimen
- ClinicalTrials.gov ID
- NCT03117634
- Acronym / sponsor ID
- R1448/31/2017
- Keywords
- anti vegf, aflibercept, treat and extend
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Singapore National Eye CentreOther government
- Collaborators
- Bayer
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 18 Apr 2017 (actual)
- Results
- Posted 18 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Polypoidal choroidal neovasculopathy (PCV) is a subtype of wet age related macula degeneration (AMD) occuring more commonly in the Asian population. Besides the phenotypic differences, PCV is thought to have a lesser response to anti VEGF therapy which is the mainstay of treatment for other typical wet AMD. Recent trial data suggest that a combination with photodynamic therapy may help in the visual and anatomical outcome of PCV, and emerging evidence shows favourable outcomes the newer anti VEGF agent, aflibercept 2mg monotherapy. These trials however, have assessed aflibercept in a strict 2mg every 8 weekly regime.
In the clinical setting, a significant an unmet need in the management of PCV is a tailored treatment regime. Here we propose a treatment regimen based on disease activity for PCV with aflibercept mono therapy. A limitation of the 2q8 regime is that it is fixed and does not vary regardless of polyp closure or anatomical outcome at the first time point of assessment (month 3). We hypothesize that after the initial 3 monthly injections of aflibercept, about 50% of PCV will close and become quiescent, and in the remaining 50%, a further 3 monthly injections will increase overall polyp closure rate. After a loadings phase of either 3 or 6 months, all eyes will start on a treat and extend regime (T\&E), with a minimum period of 8 weeks and a maximum of 12 weeks between treatments with 2 week increments if PCV remains quiescent. The proposed study aims to evaluate the efficacy of a modified treat and extend regime based on disease activity with aflibercept monotherapy for PCV.
Detailed description
Age related macular degeneration (AMD) is one of the leading causes of blindness worldwide. In its exudative or wet form, choroidal neovascularization (CNV) causes an exudative maculopathy resulting in sudden loss of vision with severe effects on patients' quality of life.1,2 Intra vitreal injections of anti-vascular endothelial growth factor agents (anti-VEGF) agents have become the mainstay of treatment for AMD CNV and have been shown to have favorable outcomes in most AMD CNV subtypes.3,4 In the Asian population however, a particular subtype called polypoidal choroidal vasculopathy (PCV), which affects about 50% of exudative maculopathy, has been shown to have less favorable response to anti-VEGF therapy.5,6 The EVEREST trial, a randomized controlled trial which compares the efficacy of photodynamic therapy (PDT) with or without ranibizumab for treatment of PCV showed that PDT with or without anti VEGF improved polyp closure rate on angiographic assessment but this trial did not take into account vision as a primary end point.7 PDT appears work through its effects on choroidal vasculature, hence making it relevant to PCV which is increasingly thought to be a condition on the pachychoroid spectrum.8 PDT however, as a treatment modality presents several disadvantages. Firstly, PCV often presents as a widely distributed lesion, making it difficult to treat, with a single beam of PDT. Secondly, PDT is limited in its ability to treat lesions in the peripapillary area as there is risk of damage to the optic nerve. Thirdly, features commonly associated with PCV such as a large pigment epithelial detachment (PED) or extensive submacular hemorrhages are not usually suitable for PDT. Fourthly, there is a risk of long-term choroidal atrophy especially if repeated treatments are administered.8,9
There is emerging evidence for the use of aflibercept monotherapy in PCV. Reports range from small case series and retrospective studies to larger prospective studies. Recent data from the PLANET study showed that monotherapy of aflibercept resulted in similar letter gains in visual acuity as compared to combination treatment with PDT at 1 year. Polyp closure rate was also similar between the two groups at 38.9% with monotherapy and 44.8% with combination therapy. The VAULT and APOLLO studies suggest vision and anatomical improvements with 66-72% polyp closure in 1 year.10 These trials however, use a fixed dosing regimen (3 monthly loading doses of 2mg aflibercept followed by fixed dosing every 8 weeks (2q8) totaling 7 injections in 1 year). In addition to resolution of subretinal fluid, recent studies using the novel OCT-angiography (OCT-A) to evaluate choroidal vasculature suggests re-modelling of choroidal vasculature may also be an important therapeutic effect. We reported more prominent reduction in choroidal vessel calibre after combination treatment with PDT and bevacizumab compared to bevacizumab monotherapy. The effect of Aflibercept on choroidal vasculature has been less well studied. Some evidence however, suggested aflibercept may have more profound effect on choroidal vasculature with the reducing choroidal thickness than ranibizumab or bevacizumab.
A significant unmet need in the management of PCV with anti VEGF monotherapy is a practical way of treating patients in the real world setting that maximizes efficacy with minimal number of visits and injections. Clinical trial regimes follow a rigid treatment algorithm that aim to maximize response. In the clinical setting, these regimes are impractical in "real world" patients. Regular intensive course of treatment involves lengthy visits which include consultation time, clinical examination, retinal imaging, and often an intra vitreal injection. In clinical practice this often result in treatment fatigue and in a co-payment healthcare environment in Singapore, may also result in significant financial burden to the patient and society.
While aflibercept affords an 8 weekly treatment regime which is better than other monthly anti VEGF therapy regimes, trial regimes still do not take into account individual patients' disease patterns. This study aims to take disease activity into account to tailor treatment regimes specific for patients. In addition, it aims to provide insight into the outcomes of patients on a more clinically relevant treat and extend (T\&E) regime which changes the treatment tempo in relation to disease activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, 2-arm, Non-inferiority, interventional study
| Arm | Type | Receives |
|---|---|---|
| Fixed dosing group (2Q8) | Active comparator | Drug: Fixed Dosing with Aflibercept 2mgFixed Dosing with Aflibercept 2mg will be administered at a fixed regime at 8 week intervals through to week 52. |
| Treat and Extend group (T&E) | Experimental | Drug: Treat and Extend with Aflibercept 2mgReassessment at week 12 (month 3) by repeat examination for disease activity by OCT and indocyanine green angiography (ICGA). Subsequent treatment regime of Treat and Extend with Aflibercept 2mg will depend on disease activity at this point. |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Male or female study participants, age >=45 years of age at the time of informed consent.
- Best corrected ETDRS visual acuity score <= 78 (ie 20/32 or worse)
- Diagnosis of PCV based on ICGA
- Media clarity, pupillary dilation and individual cooperation sufficient for study procedure including fundus photography.
- Able and willing to provide informed consent.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Treat and Extend with Aflibercept 2mgAlso: T&EDrug treatment regime which allows extension of treatment interval based on disease activity | Drug | Treat and Extend group (T&E) |
| Fixed Dosing with Aflibercept 2mgAlso: 2Q8Fixed 8 weekly dosing regime throughout the study duration | Drug | Fixed dosing group (2Q8) |
Primary outcome
Mean Change in Best Corrected Visual Acuity (BCVA)
Time frame: From Baseline to Week 52
Mean Change in Best corrected visual acuity (BCVA) from baseline to week 52 for personalized and fixed regimen. it is a Non-inferiority of personalized to fixed regimen for mean change in BCVA from baseline to week 52 (Non-inferiority is considered as -5 ETDRS Letters difference )
3 secondary outcomes
Mean Change in Central Sub Field Thickness
Time frame: From Baseline to Week 52
Number of Participants With Complete Polypoidal Lesion Closure
Time frame: At Week 52
Number of Injections
Time frame: From Baseline to Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33574033Teo KYC, Jordan-Yu JM, Tan ACS, Yeo IYS, Mathur R, Chan CM, Wong TY, Chakravarthy U, Cheung CMG. Efficacy of a novel personalised aflibercept monotherapy regimen based on polypoidal lesion closure in participants with polypoidal choroidal vasculopathy. Br J Ophthalmol. 2022 Jul;106(7):987-993. doi: 10.1136/bjophthalmol-2020-318354. Epub 2021 Feb 11.
- Individual participant dataSharing planned: No
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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.
Gemmy Cheung principal investigator
SNEC
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 Treat and Extend with Aflibercept 2mg and Fixed Dosing with Aflibercept 2mg in people with Age Related Macular Degeneration and Polypoidal Choroidal Vasculopathy, run by Singapore National Eye Centre at 1 site in Singapore.
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 29 inclusion and 0 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: finished, as of the sponsor's last update on 18 Aug 2021. 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 Singapore. 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?
Yes. Results are posted in the registry (first posted 18 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change in Best Corrected Visual Acuity (BCVA) (time frame: From Baseline to Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03117634, which also lists 1 linked publication.
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 18 Aug 2021.