Proliferative VitreoretinopathyPhase 1SIGHTNCT04830878
Methotrexate For The Prevention and Treatment of Proliferative Vitreoretinopathy in Pediatric Patients
A Phase 1 study testing Methotrexate in people with Proliferative Vitreoretinopathy, run by Stanford University at 1 site in United States.
Trial summary
Rhegmatogenous retinal detachment (RRD) is a sight-threatening condition. Children with RRD usually present late with clinical features of longstanding RRD, specifically a serious condition named: proliferative vitreoretinopathy (PVR). Therefore, children with RRD often have poorer outcomes. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Proliferative Vitreoretinopathy
- What is being tested?
- Methotrexate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2021to Apr 2024
- Phase
- Phase 1
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ability to get informed consent from a parent or a legal guardian of the child and attend all study visits.
- Males or females 18 years old or younger.
- Subject is undergoing vitrectomy for either i. initial retinal detachment with or without PVR ii. recurrent retinal detachment due to grade A or higher of proliferative vitreoretinopathy.
- Female subjects of childbearing potential must not be pregnant or breast-feeding, must have a negative serum pregnancy test at screening, and must be willing to undergo pregnancy tests throughout the study.
- Female subjects of childbearing potential and male subjects able to father children must (a) abstain from intercourse throughout the course of the study or (b) agree to practice acceptable methods of contraception throughout the course of the study (i.e., intrauterine device, oral contraceptives, barrier method, or other contraception deemed adequate by the investigator).
Who cannot join
- Ocular or periocular infection in either eye including (but not limited to):
- History of herpetic infection in the study eye(s) or adnexa.
- Presence of known active or inactive toxoplasmosis or toxoplasmosis scar in either eye.
- History of cytomegalovirus infection or clinical evidence of active cytomegalovirus infection at screening and/or Day 1.
- Pupillary dilation inadequate for quality stereoscopic fundus photography in the study eye(s).
- Media opacity that would limit clinical visualization in the study eye(s) and, in the opinion of the investigator, could not be repaired or improved during the RD surgery.
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- Other planned eye surgery during the course of the trial
- Corneal opacity in the study eye(s) that would preclude reliable assessment of the posterior segment.
- Uncontrolled glaucoma in the study eye(s), evidenced by an intraocular pressure (IOP) > 21 mmHg while on maximum medical therapy, or chronic hypotony (unmeasurable eye pressure).
- Subjects should not be currently undergoing treatment with one of the following at the time of RD diagnosis: systemic steroids, methotrexate, azathioprine, or mycophenolate mofetil (or an equivalent drug, e.g., mycophenolic acid) or other immunomodulatory therapies.
- Malignancy in remission for less than 5 years prior to study participation.
- Allergy or hypersensitivity to investigational product or other study related procedures/medications.
- Any recent systemic infection (excluding common cold) within 30 days of Day 1.
- Known to be immunocompromised.
- History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease condition that contraindicates the use of an investigational drug, might affect the interpretation of the results of the study, or renders the subject at high risk for treatment complications.
- Any uncontrolled systemic disease, except stable syndromic conditions.
- Females who are pregnant or lactating and females of child-bearing potential who are not using adequate contraceptive precautions (i.e., intrauterine device, oral contraceptives, barrier method, or other contraception deemed adequate by the investigator).
- Participation in other investigational drug (oral or topical therapy) or device clinical trials within 30 days prior to Day 1 and/or participation in other investigational drug (intravitreal injection therapy) within 3 months or 5 half-lives (whichever is longer) prior to Day 1 or planning to participate in other investigational drug or device clinical trials during a time which would overlap with the duration of the study. This includes both ocular and non-ocular clinical trials. Exposure to investigational biologics should be discussed with the investigators.
- In addition, the investigator may declare a subject ineligible for any sound reason.
- Chest X-ray within 3 months prior to initiation of systemic MTX that shows active pulmonary diseases of any etiology.
Trial locations and contacts
1 site in 1 country.
United States1 site
Byers Eye Institute at Stanford University and Lucille Packard Children Hospital
Palo Alto, California, 94303
About this study
Official title: A Phase I, Multicenter, Uncontrolled, Open Label Study Assessing the Efficacy and Safety of a Combination of Systemic and Intravitreal Injections of Methotrexate for the Prevention and Treatment of Proliferative Vitreoretinopathy in Pediatric Patients With RheGmatogenous Retinal DetacHmenT (the SIGHT Study)
Rhegmatogenous retinal detachment (RRD) is a sight-threatening condition. Children with RRD usually present late with clinical features of longstanding RRD, specifically a serious condition named: proliferative vitreoretinopathy (PVR). Therefore, children with RRD often have poorer outcomes. The objective of this study is to investigate the efficacy and safety of methotrexate in the treatment and prevention of PVR. Methotrexate is a medication that has been used to treat inflammatory conditions in children and adults for a long time and it has been recently used to treat PVR in adults.
- Conditions
- Proliferative Vitreoretinopathy
- Being tested
- Methotrexate
- Medical subject headings
- Vitreoretinopathy, Proliferative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Systemic and intraoperative intravitreal injection of methotrexate
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Methotrexate treatment Receives: Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of Retinal Detachment
Number of Participants with Recurrent Retinal Detachment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study startApr 2021 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionApr 2024 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proliferative VitreoretinopathyStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edward Wood, MD, Principal investigator, Stanford UniversityQuan Dong Nguyen, MD, MSc, Principal investigator, Stanford UniversityAhmad Al-Moujahed, MD, PhD, MPH, Principal investigator, Stanford UniversityHashem Ghoraba, MD, Principal investigator, Stanford UniversityDarius Moshfeghi, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830878
- Sponsor's protocol ID
- IRB-59989
- Acronym
- SIGHT
- Status last verified
- Apr 2023
- First submitted
- 31 Mar 2021
- Last updated
- 20 Apr 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multicenter, Uncontrolled, Open Label Study Assessing the Efficacy and Safety of a Combination of Systemic and Intravitreal Injections of Methotrexate for the Prevention and Treatment of Proliferative Vitreoretinopathy in Pediatric Patients With RheGmatogenous Retinal DetacHmenT (the SIGHT Study)
- ClinicalTrials.gov ID
- NCT04830878
- Acronym / sponsor ID
- SIGHT / IRB-59989
- Conditions
- Proliferative Vitreoretinopathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 5 Apr 2021 (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.
Rhegmatogenous retinal detachment (RRD) is a sight-threatening condition. Children with RRD usually present late with clinical features of longstanding RRD, specifically a serious condition named: proliferative vitreoretinopathy (PVR). Therefore, children with RRD often have poorer outcomes. The objective of this study is to investigate the efficacy and safety of methotrexate in the treatment and prevention of PVR. Methotrexate is a medication that has been used to treat inflammatory conditions in children and adults for a long time and it has been recently used to treat PVR in adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: MethotrexateMethotrexate treatment |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Ability to get informed consent from a parent or a legal guardian of the child and attend all study visits.
- Males or females 18 years old or younger.
- Subject is undergoing vitrectomy for either i. initial retinal detachment with or without PVR ii. recurrent retinal detachment due to grade A or higher of proliferative vitreoretinopathy.
- Female subjects of childbearing potential must not be pregnant or breast-feeding, must have a negative serum pregnancy test at screening, and must be willing to undergo pregnancy tests throughout the study.
- Female subjects of childbearing potential and male subjects able to father children must (a) abstain from intercourse throughout the course of the study or (b) agree to practice acceptable methods of contraception throughout the course of the study (i.e., intrauterine device, oral contraceptives, barrier method, or other contraception deemed adequate by the investigator).
Key exclusion criteria (20 listed)
- Ocular or periocular infection in either eye including (but not limited to):
- Pupillary dilation inadequate for quality stereoscopic fundus photography in the study eye(s).
- Media opacity that would limit clinical visualization in the study eye(s) and, in the opinion of the investigator, could not be repaired or improved during the RD surgery.
- Other planned eye surgery during the course of the trial
- Corneal opacity in the study eye(s) that would preclude reliable assessment of the posterior segment.
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 |
|---|---|---|
| MethotrexateSystemic and intraoperative intravitreal injection of methotrexate | Drug | Treatment |
Primary outcome
Recurrence of Retinal Detachment
Time frame: 6 months
Number of Participants with Recurrent Retinal Detachment
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 20 Apr 2023.
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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.
Edward Wood, MD principal investigator
Stanford University
Quan Dong Nguyen, MD, MSc principal investigator
Stanford University
Ahmad Al-Moujahed, MD, PhD, MPH principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Methotrexate in people with Proliferative Vitreoretinopathy, run by Stanford 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 20 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 20 Apr 2023. 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 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.
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?
Recurrence of Retinal Detachment (time frame: 6 months). 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 20 Apr 2023.