Neovascular Age-related Macular DegenerationPhase 1/2NCT03216538
Safety and Efficacy of AS101 1% Oral Solution in Patients With Neovascular Age-Related Macular Degeneration (AMD)
A Phase 1/2 study testing AS101 1% oral solution in people with Neovascular Age-related Macular Degeneration, run by Feramda at 1 site in Israel.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of AS101 1% oral solution as compared to placebo in patients with neovascular Age-Related Macular Degeneration (AMD). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration
- What is being tested?
- AS101 1% oral solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 8 Oct 2018to 1 Jul 2020
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is diagnosed with CNV from AMD in one or both eyes and eligible for any anti-VEGF treatment in one or two study eyes.
- Patient is 50 years of age or older.
- Patient underwent at least 3 consecutive Intravitreal anti VEGF injections of the same kind , Ranibizumab (Lucentis) or Bevacizumab (Avastin) in the study eye and have sub retinal or intraretinal fluid at day 1, as found in OCT examination.
- Patient must understand and sign the IRB-approved informed consent document for the study.
- Patient must have BCVA of at least 20/200 in the study eye.
- While unlikely, female patients of childbearing potential must not be pregnant or breast-feeding an must be willing to undergo serum pregnancy tests throughout the study. Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child-bearing potential.
- Both female patients of childbearing potential and male patients able to father a child must have (or have a partner who has) an acceptable method of contraception (such as hormonal or condoms) throughout the course of the study and for 4 weeks after the last study medication administration.
- Patient must be willing and able to comply with the study procedures.
Who cannot join
- Patient exhibits evidence of retinal angiomatous proliferation in the study eye.
- Patient has retinal-choroidal anastomosis in the study eye.
- Patient has a history of treatment for CNV in the study eye with verteporfin, transpupillary thermotherapy, laser photocoagulation, external beam radiation therapy, or other local treatment (such as submacular surgery).
- Patient has a history of systemic, periocular or intraocular steroid use at any time during the 12 weeks prior to enrollment.
- Patient has a corneal melting, necrotizing keratitis/scleritis, scleritis of an infectious etiology or impending vision loss.
- Patient has a known underlying systemic disease with evidence of a serious or potentially lethal uncontrolled active disease in one or more extraocular organ systems for which a defined effective medical regimen is indicated.
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- Patient has active pulmonary tuberculosis or active viral hepatitis.
- Patient has a significant active infection.
- Patient has significant renal or hepatic function impairment greater than mild (grade 2) as per CTCAE v4.0 or hypercholesterolemia uncontrolled by medication and/or diet.
- Pregnant patients or lactating.
- Patient has a history of malignancy within the past two years other than non-melanoma skin cancer.
- Patient has an autoimmune systemic disease requiring immunosuppressive treatment or patient has other medical condition that renders the patient immunocompromised.
- Patient received a live vaccine within past six weeks.
- Patient has significant ocular or periocular inflammation or infection in either eye.
- Patient has the presence of active or inactive toxoplasmosis in the study eye.
- Patient is scheduled for surgery during study.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II, Single-center, Randomized Double Masked Placebo Controlled Study to Evaluate the Safety and Efficacy of Treatment With AS101 1% Oral Solution in Patients With Neovascular Age-Related Macular Degeneration (AMD)
The purpose of this study is to evaluate the safety and efficacy of AS101 1% oral solution as compared to placebo in patients with neovascular Age-Related Macular Degeneration (AMD).
AMD Patients who underwent 3 consecutive intravitreal anti VEGF injections and have sub retinal or intraretinal fluid at day 1 of study will be treated orally by AS101 1% solution or placebo once daily for 24 weeks and will be tested for sub retinal or intraretinal fluid every 4 weeks by OCT examination. In case of fluid in macula anti intravitreal anti VEGF injections will be given the same day as needed (PRN). Safety evaluation will be assessed by adverse events related to treatment of 1% AS101 oral solution or placebo. Efficacy will be evaluated in terms of duration of fluid free macula in the AS101 treated group as as compared to placebo treated group;
Read the detailed description
A Phase I/II, single-center, randomized double masked placebo controlled study to evaluate the safety and efficacy of AS101 1% oral solution or placebo once daily for 24 weeks in treating patients with neovascular AMD.
Following confirmation of patient eligibility (as detailed in in the inclusion criteria), patients who meet all of the inclusion and exclusion criteria will be enrolled.
On day 1 patients will be randomly allocated to one of the two following study arms in a 1:1 ratio and in a masked manner: (1) AS101 1% oral solution (2) Placebo oral solution. Patients of both study arms will be instructed on how to administer orally the drug at home once daily for 24 weeks. Patients will stop taking the study oral solution at week 24 treatment visit.
In case of existence of fluid in macula, determined as intra retinal or sub-retinal fluid in the macula (as required in inclusion criteria) the standard to care anti-VEGF intravitreal therapy (Lucentis or Avastin, same as the treatment prior to study start) will be injected by a pro re nata (PRN).
Every 4 weeks the investigator will assess if a patient has a fluid free macula based on clinical evaluation, OCT and FA findings In case of fluid in macula the standard of care anti intravitreal anti VEGF injections (Lucentis or Avastin, same as the treatment prior to study start) will be given the same day by a pro re nata (PRN).
The investigator will monitor the occurrence of any adverse event. The study will be completed at week 24 and the study drug, 1% AS101 oral solution or placebo, will be collected from patients.
At week 28 (4 weeks after treatment completion) all patients will be invited for safety assessment.
If the investigator determines that there is a disease progression study therapy is to be discontinued prior to 24 weeks of treatment. Last observation carried forward (LOCF) technique will be used to analyze such patients.
Efficacy will be evaluated in terms of duration of fluid free macula in the AS101 treated group as compared to placebo treated group;
- Being tested
- AS101 1% oral solution, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AS101 1% oral solutionDrug
0.4 ml daily p.o.
PlaceboDrug
0.4 ml daily p.o.
| Study group | Role | What they receive |
|---|---|---|
| AS101 1% oral solution | Active comparator | Daily dose 0.4 ml administered orally Receives: Drug: AS101 1% oral solution |
| Placebo | Placebo comparator | Daily dose of 0.4 ml administered orally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessed by incidence and severity of treatment emerged ocular and non-ocular adverse events
as assessed by visual acuity measurement, ophthalmic examinations, vital signs, laboratory tests and adverse events related to 1% AS101 oral solution as compared to placebo.
Measured: 28 weeks
Secondary outcomes (5)
Duration of fluid free macula in average
As assessed every 4 weeks by OTC
Measured: 28 weeks
Duration of fluid free macula
Proportion in number of patients that had an increase in the duration of fluid free macula;
Measured: 24 weeks
Best corrected visual acuity (BCVA)
changes in BCVA using the Early treatment diabetic retinopathy study (ETDRS) chart;
Measured: 24 Weeks
Central retinal subfield thickness (CRT)
CRT as measured by optical coherence tomography (OCT);
Measured: 24 weeks
Lesion size in the macula
Changes as demonstrated by fluorescein angiography (FA) if feasible;
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study start8 Oct 2018
- Primary completion1 May 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- On day 1 patients will be randomly allocated to one of the two following study arms in a 1:1 ratio and in a masked manner: (1) AS101 1% oral solution (2) Placebo oral solution. Patients of both study arms will be instructed on how to administer orally the drug at home once daily for 24 weeks. Patients will stop taking the study oral solution at week 24 treatment visit.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Feramda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03216538
- Sponsor's protocol ID
- AS101 AMD# 1ֹ
- Status last verified
- Nov 2020
- First submitted
- 7 Jul 2017
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Single-center, Randomized Double Masked Placebo Controlled Study to Evaluate the Safety and Efficacy of Treatment With AS101 1% Oral Solution in Patients With Neovascular Age-Related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT03216538
- Acronym / sponsor ID
- AS101 AMD# 1ֹ
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- FeramdaIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 13 Jul 2017 (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.
The purpose of this study is to evaluate the safety and efficacy of AS101 1% oral solution as compared to placebo in patients with neovascular Age-Related Macular Degeneration (AMD).
AMD Patients who underwent 3 consecutive intravitreal anti VEGF injections and have sub retinal or intraretinal fluid at day 1 of study will be treated orally by AS101 1% solution or placebo once daily for 24 weeks and will be tested for sub retinal or intraretinal fluid every 4 weeks by OCT examination. In case of fluid in macula anti intravitreal anti VEGF injections will be given the same day as needed (PRN). Safety evaluation will be assessed by adverse events related to treatment of 1% AS101 oral solution or placebo. Efficacy will be evaluated in terms of duration of fluid free macula in the AS101 treated group as as compared to placebo treated group;
Detailed description
A Phase I/II, single-center, randomized double masked placebo controlled study to evaluate the safety and efficacy of AS101 1% oral solution or placebo once daily for 24 weeks in treating patients with neovascular AMD.
Following confirmation of patient eligibility (as detailed in in the inclusion criteria), patients who meet all of the inclusion and exclusion criteria will be enrolled.
On day 1 patients will be randomly allocated to one of the two following study arms in a 1:1 ratio and in a masked manner: (1) AS101 1% oral solution (2) Placebo oral solution. Patients of both study arms will be instructed on how to administer orally the drug at home once daily for 24 weeks. Patients will stop taking the study oral solution at week 24 treatment visit.
In case of existence of fluid in macula, determined as intra retinal or sub-retinal fluid in the macula (as required in inclusion criteria) the standard to care anti-VEGF intravitreal therapy (Lucentis or Avastin, same as the treatment prior to study start) will be injected by a pro re nata (PRN).
Every 4 weeks the investigator will assess if a patient has a fluid free macula based on clinical evaluation, OCT and FA findings In case of fluid in macula the standard of care anti intravitreal anti VEGF injections (Lucentis or Avastin, same as the treatment prior to study start) will be given the same day by a pro re nata (PRN).
The investigator will monitor the occurrence of any adverse event. The study will be completed at week 24 and the study drug, 1% AS101 oral solution or placebo, will be collected from patients.
At week 28 (4 weeks after treatment completion) all patients will be invited for safety assessment.
If the investigator determines that there is a disease progression study therapy is to be discontinued prior to 24 weeks of treatment. Last observation carried forward (LOCF) technique will be used to analyze such patients.
Efficacy will be evaluated in terms of duration of fluid free macula in the AS101 treated group as compared to placebo treated group;
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- On day 1 patients will be randomly allocated to one of the two following study arms in a 1:1 ratio and in a masked manner: (1) AS101 1% oral solution (2) Placebo oral solution. Patients of both study arms will be instructed on how to administer orally the drug at home once daily for 24 weeks. Patients will stop taking the study oral solution at week 24 treatment visit.
| Arm | Type | Receives |
|---|---|---|
| AS101 1% oral solution | Active comparator | Drug: AS101 1% oral solutionDaily dose 0.4 ml administered orally |
| Placebo | Placebo comparator | Drug: PlaceboDaily dose of 0.4 ml administered orally |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient is diagnosed with CNV from AMD in one or both eyes and eligible for any anti-VEGF treatment in one or two study eyes.
- Patient is 50 years of age or older.
- Patient underwent at least 3 consecutive Intravitreal anti VEGF injections of the same kind , Ranibizumab (Lucentis) or Bevacizumab (Avastin) in the study eye and have sub retinal or intraretinal fluid at day 1, as found in OCT examination.
- Patient must understand and sign the IRB-approved informed consent document for the study.
- Patient must have BCVA of at least 20/200 in the study eye.
Key exclusion criteria (17 listed)
- Patient exhibits evidence of retinal angiomatous proliferation in the study eye.
- Patient has retinal-choroidal anastomosis in the study eye.
- Patient has a history of treatment for CNV in the study eye with verteporfin, transpupillary thermotherapy, laser photocoagulation, external beam radiation therapy, or other local treatment (such as submacular surgery).
- Patient has a history of systemic, periocular or intraocular steroid use at any time during the 12 weeks prior to enrollment.
- Patient has a corneal melting, necrotizing keratitis/scleritis, scleritis of an infectious etiology or impending vision loss.
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 |
|---|---|---|
| AS101 1% oral solution0.4 ml daily p.o. | Drug | AS101 1% oral solution |
| Placebo0.4 ml daily p.o. | Drug | Placebo |
Primary outcome
Safety assessed by incidence and severity of treatment emerged ocular and non-ocular adverse events
Time frame: 28 weeks
as assessed by visual acuity measurement, ophthalmic examinations, vital signs, laboratory tests and adverse events related to 1% AS101 oral solution as compared to placebo.
5 secondary outcomes
Duration of fluid free macula in average
Time frame: 28 weeks
Duration of fluid free macula
Time frame: 24 weeks
Best corrected visual acuity (BCVA)
Time frame: 24 Weeks
Central retinal subfield thickness (CRT)
Time frame: 24 weeks
Lesion size in the macula
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AS101 1% oral solution in people with Neovascular Age-related Macular Degeneration, run by Feramda at 1 site in Israel.
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 8 inclusion and 17 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 4 Nov 2020. 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 Israel. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety assessed by incidence and severity of treatment emerged ocular and non-ocular adverse events (time frame: 28 weeks). 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 4 Nov 2020.