Age-Related Macular Degeneration (AMD)Phase 2NCT02348359
X-82 to Treat Age-related Macular Degeneration
A Phase 2 study testing X-82 and Anti-VEGF in people with Age-Related Macular Degeneration (AMD) and Macular Degeneration, run by Tyrogenex at 35 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of X-82 in the treatment of vision loss due to wet AMD. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-Related Macular Degeneration (AMD), Macular Degeneration, Exudative Age-related Macular Degeneration
- What is being tested?
- X-82 and Anti-VEGF
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- 35 sitesUnited States
- Study dates
- 16 Mar 2015to 12 Jan 2018
- Phase
- Phase 2
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants mush have wet AMD which has been diagnosed and treated with anti-VEGF in one or both eyes for at least 6 months prior to joining the study and has required at least two prior injections of intravitreal (ivt) anti-VEGF at intervals of not greater than 6 weeks for the past two injections in the eye that is selected to be the study eye.
- Must have demonstrated a reduction in macular fluid or macular thickness in the study eye 14 days following an anti-VEGF injection at Screening Visit 1
- Early Treatment Diabetic Retinopathy (ETDRS) Best Corrected Visual Acuity (BCVA) of 25 letters (20/320) or better in both eyes
Who cannot join
- Previous vitrectomy to the study eye within 30 days of Screening Visit 1
- Choroidal neovascularization (CNV) due to causes other than AMD
- Proliferative diabetic retinopathy in either eye
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
Study site
Abilene, Texas
Study site
Albany, New York
Study site
Asheville, North Carolina
Study site
Augusta, Georgia
Study site
Austin, Texas
Study site
Baltimore, Maryland
Study site
Beverly Hills, California
Study site
Bloomfield, New Jersey
Study site
Boston, Massachusetts
Study site
Charlotte, North Carolina
Study site
Cleveland, Ohio
Study site
Colorado Springs, Colorado
Study site
Fort Myers, Florida
Study site
Glen Burnie, Maryland
Study site
Golden, Colorado
Study site
Houston, Texas
Study site
Huntington Beach, California
Study site
Indianapolis, Indiana
Study site
Lakeland, Florida
Study site
Lemont, Illinois
Study site
Melbourne, Florida
Study site
Miami, Florida
Study site
Nashville, Tennessee
Study site
New London, Connecticut
Study site
New York, New York
Study site
Oak Forest, Illinois
Study site
Palm Beach Gardens, Florida
Study site
Portsmouth, New Hampshire
Study site
Redlands, California
Study site
Richmond, Virginia
Study site
Sacramento, California
Study site
Springfield, Massachusetts
Study site
The Woodlands, Texas
Study site
Tucson, Arizona
Study site
Youngstown, Ohio
About this study
Official title: A Randomized, Double-Masked, Placebo-Controlled, Dose- Finding, Non-Inferiority Study of X-82 Plus Prn Intravitreal (Ivt) Anti-VEGF Compared to Prn Ivt Anti-VEGF Monotherapy in Neovascular AMD
The purpose of this study is to evaluate the safety and efficacy of X-82 in the treatment of vision loss due to wet AMD.
Read the detailed description
Subjects will be randomized in a 1:1:1:1 ratio to the following dose groups:
- X-82 50 mg plus ivt anti-VEGF prn
- X-82 100 mg plus ivt anti-VEGF prn
- X-82 200 mg plus ivt anti-VEGF prn
- Placebo plus ivt anti-VEGF prn
Subjects will be treated for a total of 52 weeks with one of three doses of X-82 or placebo.
Primary Efficacy Outcome:
The primary efficacy outcome is the change in visual acuity score from Day -1 to 52 Weeks after randomization.
Safety Outcomes:
Systemic and ocular safety will be evaluate by assessing ECG, laboratory analyses, adverse events and serious adverse events.
Approximately 132 subjects will be randomized into one of the four arms (33 subjects per dose group).
- Conditions
- Age-Related Macular Degeneration (AMD), Macular Degeneration, Exudative Age-related Macular Degeneration, AMD, Macular Degeneration, Age-related, 10, Eye Diseases
- Being tested
- X-82, Anti-VEGF, Placebo
- Keywords
- Vascular Endothelial Growth Factor (VEGF), Platelet Derived Growth Factor (PDGF), AMD
- Medical subject headings
- Macular Degeneration, Macular Degeneration, Age-Related, 10, Eye Diseases, Retinal Degeneration, Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X-82Drug
Also called X-82 tablets
Anti-VEGFDrug
Also called Aflibercept (Eylea), Ranibizumab (Lucentis), Bevacizumab (Avastin)
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 50 mg of X-82 plus ivt anti-VEGF prn | Experimental | Subject will administer one 50 mg tablet of X-82 and one placebo tablet once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit. Receives: Drug: X-82; Drug: Anti-VEGF |
| 100 mg of X-82 plus ivt anti-VEGF prn | Experimental | Subject will administer two 50 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit. Receives: Drug: X-82; Drug: Anti-VEGF |
| 200 mg of X-82 plus ivt anti-VEGF prn | Experimental | Subject will administer two 100 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit. Receives: Drug: X-82; Drug: Anti-VEGF |
| Placebo plus ivt anti-VEGF prn | Placebo comparator | Subject will administer two placebo tablets once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit. Receives: Drug: Anti-VEGF; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Visual Acuity Score From Day -1 to Week52
The primary outcome is the change in the visual acuity score from Day -1 to 52 weeks after randomization.
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study start16 Mar 2015
- Primary completion12 Dec 2017
- Study completion12 Jan 2018
Why it stopped: Interim analysis found study had achieved primary objective
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.
- Other trials for 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tyrogenex
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SynteractHCR, International Drug Development Institute
- Responsible party
- Sponsor
- Investigators
- Daniel E Salazar, PhD, Principal investigator, Study PI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02348359
- Sponsor's protocol ID
- X82-OPH-201
- Status last verified
- Feb 2022
- First submitted
- 21 Jan 2015
- Last updated
- 11 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Masked, Placebo-Controlled, Dose- Finding, Non-Inferiority Study of X-82 Plus Prn Intravitreal (Ivt) Anti-VEGF Compared to Prn Ivt Anti-VEGF Monotherapy in Neovascular AMD
- ClinicalTrials.gov ID
- NCT02348359
- Acronym / sponsor ID
- X82-OPH-201
- Conditions
- Age-Related Macular Degeneration (AMD), Macular Degeneration, Exudative Age-related Macular Degeneration, AMD, Macular Degeneration, Age-related, 10, Eye Diseases
- Keywords
- Vascular Endothelial Growth Factor (VEGF), Platelet Derived Growth Factor (PDGF), AMD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis found study had achieved primary objective
- Enrolment
- 157 participants (actual)
- Lead sponsor
- TyrogenexIndustry (pharma, biotech, devices)
- Collaborators
- SynteractHCR, International Drug Development Institute
- Study start
- 16 Mar 2015 (actual)
- Primary completion
- 12 Dec 2017 (actual)
- Study completion
- 12 Jan 2018 (actual)
- First posted
- 28 Jan 2015 (estimated)
- Results
- Posted 27 Jun 2018
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 X-82 in the treatment of vision loss due to wet AMD.
Detailed description
Subjects will be randomized in a 1:1:1:1 ratio to the following dose groups:
- X-82 50 mg plus ivt anti-VEGF prn
- X-82 100 mg plus ivt anti-VEGF prn
- X-82 200 mg plus ivt anti-VEGF prn
- Placebo plus ivt anti-VEGF prn
Subjects will be treated for a total of 52 weeks with one of three doses of X-82 or placebo.
Primary Efficacy Outcome:
The primary efficacy outcome is the change in visual acuity score from Day -1 to 52 Weeks after randomization.
Safety Outcomes:
Systemic and ocular safety will be evaluate by assessing ECG, laboratory analyses, adverse events and serious adverse events.
Approximately 132 subjects will be randomized into one of the four arms (33 subjects per dose group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 50 mg of X-82 plus ivt anti-VEGF prn | Experimental | Drug: X-82, Drug: Anti-VEGFSubject will administer one 50 mg tablet of X-82 and one placebo tablet once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit. |
| 100 mg of X-82 plus ivt anti-VEGF prn | Experimental | Drug: X-82, Drug: Anti-VEGFSubject will administer two 50 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit. |
| 200 mg of X-82 plus ivt anti-VEGF prn | Experimental | Drug: X-82, Drug: Anti-VEGFSubject will administer two 100 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit. |
| Placebo plus ivt anti-VEGF prn | Placebo comparator | Drug: Anti-VEGF, Drug: PlaceboSubject will administer two placebo tablets once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants mush have wet AMD which has been diagnosed and treated with anti-VEGF in one or both eyes for at least 6 months prior to joining the study and has required at least two prior injections of intravitreal (ivt) anti-VEGF at intervals of not greater than 6 weeks for the past two injections in the eye that is selected to be the study eye.
- Must have demonstrated a reduction in macular fluid or macular thickness in the study eye 14 days following an anti-VEGF injection at Screening Visit 1
- Early Treatment Diabetic Retinopathy (ETDRS) Best Corrected Visual Acuity (BCVA) of 25 letters (20/320) or better in both eyes
Key exclusion criteria (3 listed)
- Previous vitrectomy to the study eye within 30 days of Screening Visit 1
- Choroidal neovascularization (CNV) due to causes other than AMD
- Proliferative diabetic retinopathy in either eye
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 |
|---|---|---|
| X-82Also: X-82 tablets | Drug | 100 mg of X-82 plus ivt anti-VEGF prn, 200 mg of X-82 plus ivt anti-VEGF prn, 50 mg of X-82 plus ivt anti-VEGF prn |
| Anti-VEGFAlso: Aflibercept (Eylea), Ranibizumab (Lucentis), Bevacizumab (Avastin) | Drug | 100 mg of X-82 plus ivt anti-VEGF prn, 200 mg of X-82 plus ivt anti-VEGF prn, 50 mg of X-82 plus ivt anti-VEGF prn, Placebo plus ivt anti-VEGF prn |
| Placebo | Drug | Placebo plus ivt anti-VEGF prn |
Primary outcome
Mean Change in Visual Acuity Score From Day -1 to Week52
Time frame: Week 52
The primary outcome is the change in the visual acuity score from Day -1 to 52 weeks after randomization.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Daniel E Salazar, PhD principal investigator
Study PI
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing X-82 and Anti-VEGF in people with Age-Related Macular Degeneration (AMD) and Macular Degeneration, run by Tyrogenex at 35 sites 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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites 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. 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 27 Jun 2018). 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 Visual Acuity Score From Day -1 to Week52 (time frame: Week 52). 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 11 Feb 2022.