Trial Search Results

Methotrexate For The Prevention and Treatment of Proliferative Vitreoretinopathy in Pediatric Patients

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Intervention(s):

  • Drug: Methotrexate

Phase:

Phase 1

Eligibility


Inclusion Criteria:

   1. Ability to get informed consent from a parent or a legal guardian of the child and
   attend all study visits.

   2. Males or females 18 years old or younger.

   3. 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.

   4. 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.

   5. 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).

Exclusion Criteria:

   1. Ocular or periocular infection in either eye including (but not limited to):

      1. History of herpetic infection in the study eye(s) or adnexa.

      2. Presence of known active or inactive toxoplasmosis or toxoplasmosis scar in
      either eye.

      3. History of cytomegalovirus infection or clinical evidence of active
      cytomegalovirus infection at screening and/or Day 1.

   2. Pupillary dilation inadequate for quality stereoscopic fundus photography in the study
   eye(s).

   3. 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.

   4. Other planned eye surgery during the course of the trial

   5. Corneal opacity in the study eye(s) that would preclude reliable assessment of the
   posterior segment.

   6. 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).

   7. 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.

   8. Malignancy in remission for less than 5 years prior to study participation.

   9. Allergy or hypersensitivity to investigational product or other study related
   procedures/medications.

10. Any recent systemic infection (excluding common cold) within 30 days of Day 1.

11. Known to be immunocompromised.

12. 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.

13. Any uncontrolled systemic disease, except stable syndromic conditions.

14. 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).

15. 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.

16. In addition, the investigator may declare a subject ineligible for any sound reason.

17. Chest X-ray within 3 months prior to initiation of systemic MTX that shows active
   pulmonary diseases of any etiology.

Ages Eligible for Study

N/A - 18 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Edward Wood, MD
650-723-6995