Phase 2
Completed N=6
A Pilot Study for the Evaluation of Minocycline as a Microglia Inhibitor in the Treatment of Diabetic Macular Edema
Source: ClinicalTrials.gov NCT01120899 ↗Enrolled (actual)
6
Serious AEs
16.7%
Results posted
Sep 2012
Primary outcomePrimary: Number of Study Eyes Demonstrating an Increase or Decrease in Best-corrected Visual Acuity (BCVA) of 15 or More Early Treatment Diabetic Retinopathy Study (ETDRS) Letters at 6 Months Compared to Baseline — 1 Eyes
Summary
The objective of this study is to investigate the safety and efficacy of minocycline as a microglia inhibitor in individuals with diabetic macular edema (DME).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Study Eyes Demonstrating an Increase or Decrease in Best-corrected Visual Acuity (BCVA) of 15 or More Early Treatment Diabetic Retinopathy Study (ETDRS) Letters at 6 Months Compared to Baseline |
1 | — |
| SECONDARY Change in BCVA in the Study Eye at 6 Months Compared to Baseline |
5.8 | — |
| SECONDARY Change in BCVA in the Study Eye at 12 Months Compared to Baseline |
8.0 | — |
| SECONDARY Change in BCVA in the Study Eye at 18 Months Compared to Baseline |
9.0 | — |
| SECONDARY Change in BCVA in the Study Eye at 24 Months Compared to Baseline |
9.3 | — |
| SECONDARY Percentage Change in Retinal Thickness in the Study Eye at 6 Months Compared to Baseline |
-8.1 | — |
| SECONDARY Percentage Change in Retinal Thickness in the Study Eye at 12 Months Compared to Baseline |
-12.35 | — |
| SECONDARY Percentage Change in Retinal Thickness in the Study Eye at 18 Months Compared to Baseline |
-20.09 | — |
| SECONDARY Percentage Change in Retinal Thickness in the Study Eye at 24 Months Compared to Baseline |
-20.83 | — |
| 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 |
5 | — |
| 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 |
3 | — |
| 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 |
3 | — |
| SECONDARY Number of Fellow 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 Fellow Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 12 Months Compared to Baseline |
1 | — |
| SECONDARY Number of Fellow 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 Fellow Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 24 Months Compared to Baseline |
1 | — |
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 (see Appendix 1 for definition) 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 (see Appendix 1 for definition) 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 (based on the half life of minocycline which is 11-22 hours). 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). *Oral birth control pills must be used with caution as minocycline decreases the effectiveness of some oral contraceptives. Participants already taking oral contraceptives may continue to use them, but must agree to use at least one other method of birth control while on study.
- Participants must agree to notify the study investigator or coordinator if any of their doctors initiate a new medication 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). Refer to Appendix 2 for grading.
- 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.
- Participant must agree to minimize exposure to sunlight or artificial UV rays and to wear protective clothing, sunglasses and sunscreen [minimum Sun Protection Factor (SPF) 15] if s/he must be out in the sun.
- 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 study therapy.
- 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 minocycline or any drug in the tetracycline family.
- Participant is taking any medication that could adversely interact with minocycline such as methoxyflurane.
- Participant has a blood pressure of > 180/110 (systolic above 180 OR diastolic above 110).
- If blood pressure is brought below 180/110 by anti-hypertensive treatment, patient can become eligible.
- Participant has a history of treatment with systemic anti-vascular endothelial growth factor (
Data sourced from ClinicalTrials.gov (NCT01120899). 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. Informational only — not medical advice.