Phase 2 N=7 Treatment

Dextromethorphan for Diabetic Macular Edema

Diabetic Macular Edema

Bottom Line

View on ClinicalTrials.gov: NCT01441102 ↗

Enrolled (actual)

Serious AEs

14.3%

Results posted

Jun 2015

Primary outcome: Primary: Percentage Change in Retinal Thickness in the Study Eye at 6 Months Compared to Baseline — -7.89 percentage change in retinal thickness

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Dextromethorphan hydrobromide (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: National Eye Institute (NEI)
Primary completion: Jun 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage Change in Retinal Thickness in the Study Eye at 6 Months Compared to Baseline	-7.89	—
SECONDARY Percentage Change in Retinal Thickness in the Study Eye at 12 Months Compared to Baseline	6.54	—
SECONDARY Percentage Change in Retinal Thickness in the Study Eye at 18 Months Compared to Baseline	-0.99	—
SECONDARY Percentage Change in Retinal Thickness in the Study Eye at 24 Months Compared to Baseline	-7.44	—
SECONDARY Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at 6 Months Compared to Baseline	0.60	—
SECONDARY Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at 12 Months Compared to Baseline	1.50	—
SECONDARY Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at 18 Months Compared to Baseline	4.00	—
SECONDARY Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at 24 Months Compared to Baseline	5.50	—
SECONDARY Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 6 Months Compared to Baseline	4	—
SECONDARY Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 12 Months Compared to Baseline	3	—
SECONDARY Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 18 Months Compared to Baseline	2	—
SECONDARY Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 24 Months Compared to Baseline	4	—
SECONDARY Changes in Mean Macular Sensitivity in the Study Eye at 6 Months Compared to Baseline	-2.1	—
SECONDARY Changes in Mean Macular Sensitivity in the Study Eye at 12 Months Compared to Baseline	-3.7	—
SECONDARY Changes in Mean Macular Sensitivity in the Study Eye at 18 Months Compared to Baseline	-4.9	—
SECONDARY Changes in Mean Macular Sensitivity in the Study Eye at 24 Months Compared to Baseline	-3.9	—
SECONDARY Number of Participants Withdrawn From the Study Therapy Due to Vision Loss or Adverse Events	1	—

Summary

Background: Many people with diabetes have macular edema (swelling) at the back of the eye. Macular edema can cause loss of vision. Studies suggest that inflammation may be involved in the swelling. A drug called dextromethorphan may help prevent the inflammation and the swelling. Dextromethorphan is approved for use as a cough medicine, but it has not been studied to see if it can help in diabetic macular edema. Objectives: To see if dextromethorphan can help treat diabetic macular edema. Eligibility: Individuals at least 18 years of age who have diabetic macular edema in at least one eye. Design: * This study lasts 2 years, and will require at least 14 visits to the National Eye Institute outpatient clinic. Study visits will be every month for the first 2 months and then every other month. Each visit will take about 2 to 4 hours. * Participants will be screened with a physical exam, medical history, eye exam, and blood tests. One eye with macular edema will be chosen as the study eye for testing. * Participants will take dextromethorphan twice a day, about 12 hours apart, for 2 years. A study diary will help keep track of the date, time, and number of pills taken. * Participants will have study visits once a month for the first 2 months and then every other month for the rest of the study. Each study visit will involve eye exams and blood and urine tests. * Four months after starting the study medication, participants may have laser surgery or other treatments for the macular edema, if it is needed.

Eligibility Criteria

Inclusion Criteria

Participant is 18 years of age or older.
Participant must understand and sign the protocol's informed consent document.
Female participants of childbearing potential must not be pregnant or breast-feeding, must have a negative urine pregnancy test within 24 hours prior to initiation of study medication and must be willing to undergo urine pregnancy tests throughout the study.
Female participants of childbearing potential and male participants able to father children must have (or have a partner who has) had a hysterectomy or vasectomy, be completely abstinent from intercourse or must agree to practice two acceptable methods of contraception throughout the course of the study and for one week after study medication discontinuation. Acceptable methods of contraception include:
hormonal contraception (i.e., birth control pills, injected hormones, dermal patch or vaginal ring),
intrauterine device,
barrier methods (diaphragm, condom) with spermicide, or
surgical sterilization (hysterectomy or tubal ligation).
Participant must agree to notify the study investigator or coordinator if any of his/her doctors initiate a new medication during the course of this study.
Participant must agree not to take medications containing dextromethorphan during the course of this study.
Participant must have normal renal function and liver function, or have mild abnormalities no greater than grade 1 as defined by the Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
Participant has a diagnosis of diabetic mellitus (type 1 or type 2). Any one of the following will be considered to be sufficient evidence that diabetes is present:
Current regular use of insulin for the treatment of diabetes;
Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes;
Documented diabetes by American Diabetes Association (ADA) and/or World Health Organization (WHO) criteria.
Participant has documented hemoglobin A1C 12% or less within one month of baseline.
Participants with elevated hemoglobin A1C but within the 12% or less cutoff will undergo appropriate evaluation, and unstable patients will be excluded according to the investigator's best medical judgment.
Participant agrees to refrain from consuming grapefruit juice, grapefruits and Seville oranges at any time while s/he is enrolled in this study.
Participant has at least one eye that meets the study eye criteria listed below.

Exclusion Criteria

Participant is in another investigational study and actively receiving another study medication for diabetic macular edema (DME).
Participant is unable to comply with study procedures or follow-up visits.
Participant has a known hypersensitivity to sodium fluorescein dye.
Participant has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control).
Patients in poor glycemic control who, within the last four months, initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next four months should not be enrolled.
Participant has a history of chronic renal failure requiring dialysis or kidney transplant.
Participant has a history of hepatitis or liver failure.
Participant has an allergy or hypersensitivity to dextromethorphan or levorphanol.
Participant is taking or has taken within the last 14 days any medication that could adversely interact with dextromethorphan such as selective serotonin reuptake inhibitors (SSRIs) or monoamine oxidase inhibitors (MAOIs) including but not limited to the following: almotriptan; amitriptyline; amoxapine; bromocriptine; buspirone; cabergoline; citalopram; clomipramine; desipramine; desvenlafaxine; dihydroergotamine; doxepin; duloxetine; eletriptan; ergoloid mesylates; ergotamine; escitalopram; fluoxetine; fluvoxamine; frovatriptan; imipramine; isocarboxaz

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01441102). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.