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NCT01468844

Minocycline to Treat Central Retinal Vein Occlusion

Completed Phase 1, PHASE2 Results posted Last updated 17 March 2021
What this trial tests

Phase 1, PHASE2 trial testing Minocycline in Retinal Vein Occlusion in 6 participants. Completed in 13 May 2015.

Timeline
21 December 2011
Primary endpoint
4 March 2015
13 May 2015

Quick facts

Lead sponsorNational Eye Institute (NEI)
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment6
Start date21 December 2011
Primary completion4 March 2015
Estimated completion13 May 2015
Sites2 locations across United Kingdom, United States

Drugs / interventions tested

Conditions studied

Sponsor

National Eye Institute (NEI)

Who can join

18 and older, any sex, with Retinal Vein Occlusion. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Primary Outcome is the Comparison Between the Minocycline and Placebo Groups of the Mean Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at 12 Months Compared to Baseline. Primary · Baseline to Month 12

The primary outcome measure is the mean change in best-corrected visual acuity (BCVA), as measured in ETDRS letters in the study eye at 12 months compared to baseline. Values presented represent mean and standard deviation of change from baseline at 12 months.

GroupValue95% CI
Minocycline13.3± 7.0
Placebo-2.0± NA
Number of Participants Improving ≥ 1 logOCT Scale Step in the Study Eye at 12 Months Compared to Baseline Secondary · Baseline to Month 12

Improvement of ≥ 1 logOCT scale step is defined as a decrease of ≥ 1-step on the logOCT scale. A 1-step decrease is equivalent to at least a 20% improvement of central macular thickness.

GroupValue95% CI
Minocycline2
Placebo2
Number of Participants Improving ≥ 1 logOCT Scale Step in the Study Eye at 24 Months Compared to Baseline Secondary · Baseline to Month 24

Improvement of ≥ 1 logOCT scale step is defined as a decrease of ≥ 1-step on the logOCT scale. A 1-step decrease is equivalent to at least a 20% improvement of central macular thickness.

GroupValue95% CI
Minocycline2
Placebo2
Number of Bevacizumab Injections From Baseline to 12 Months Secondary · Baseline to Month 12

The outcome measure is the number of bevacizumab injections administered to participants between baseline and 12 months.

GroupValue95% CI
Minocycline5.5± 4.4
Placebo10.5± 0.7
Number of Bevacizumab Injections From Baseline to 24 Months Secondary · Baseline to Month 24

The outcome measure is the number of bevacizumab injections administered to participants between baseline and 24 months.

GroupValue95% CI
Minocycline7.8± 8.8
Placebo16.0± 0.0
Changes in Mean Macular Sensitivity in the Study Eye as Measured by Microperimetry at 3 Months Compared to Baseline Secondary · Baseline to Month 3

The outcome measure is the mean change in macular sensitivity in the study eye at 3 months compared to baseline. Values presented represent mean and standard deviation of change from baseline at 3 months.

GroupValue95% CI
Minocycline0.8± 2.2
Placebo3.4± 0.2
Changes in Mean Macular Sensitivity in the Study Eye as Measured by Microperimetry at 6 Months Compared to Baseline Secondary · Baseline to Month 6

The outcome measure is the mean change in macular sensitivity in the study eye at 6 months compared to baseline. Values presented represent mean and standard deviation of change from baseline at 6 months.

GroupValue95% CI
Minocycline0.3± 2.8
Placebo1.1± 4.5
Changes in Mean Macular Sensitivity in the Study Eye as Measured by Microperimetry at 12 Months Compared to Baseline Secondary · Baseline to Month 12

The outcome measure is the mean change in macular sensitivity in the study eye at 12 months compared to baseline. Values presented represent mean and standard deviation of change from baseline at 12 months.

GroupValue95% CI
Minocycline-1.7± 5.5
Placebo1.3± 0.6
Changes in Mean Macular Sensitivity in the Study Eye as Measured by Microperimetry at 18 Months Compared to Baseline Secondary · Baseline to Month 18

The outcome measure is the mean change in macular sensitivity in the study eye at 18 months compared to baseline. Values presented represent mean and standard deviation of change from baseline at 18 months.

GroupValue95% CI
Minocycline-0.9± 4.0
Placebo4.5± 0.3
Changes in Mean Macular Sensitivity in the Study Eye as Measured by Microperimetry at 24 Months Compared to Baseline Secondary · Baseline to Month 24

The outcome measure is the mean change in macular sensitivity in the study eye at 24 months compared to baseline. Values presented represent mean and standard deviation of change from baseline at 24 months.

GroupValue95% CI
Minocycline-1.5± 3.3
Placebo3.9± 4.2
Mean Change in the ETDRS BCVA in the Study Eye at 24 Months Compared to Baseline Secondary · Baseline to Month 24

The outcome measure is the mean change in best-corrected visual acuity (BCVA), as measured in ETDRS letters in the study eye at 24 months compared to baseline. Values presented represent mean and standard deviation of change from baseline at 24 months.

GroupValue95% CI
Minocycline13± 0.0
Placebo-17.0± NA
Changes in Retinal Thickness in the Study Eye as Measured by Optical Coherence Tomography (OCT) at 6 Months Compared to Baseline Secondary · Baseline to Month 6

The outcome measure is the mean change in central retinal thickness in the study eye at 6 months compared to baseline. Values presented represent mean and standard deviation of change from baseline at 6 months.

GroupValue95% CI
Minocycline-272.7± 117.0
Placebo-312.0± 128.7

Adverse events — posted to ClinicalTrials.gov

Time frame: 24 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Minocycline
Serious: 1/4 (25%)
Deaths: 0/4
Placebo
Serious: 1/2 (50%)
Deaths: 0/2

Serious adverse events (3 terms)

ReactionSystemMinocyclinePlacebo
Klebsiella bacteraemiaInfections and infestations
Systemic inflammatory response syndromeGeneral disorders
Cerebellar artery thrombosisNervous system disorders
Other adverse events (57 terms — click to expand)

ReactionSystemMinocyclinePlacebo
Skin hyperpigmentationSkin and subcutaneous tissue disorders
Punctate keratitisEye disorders
NasopharyngitisInfections and infestations
DizzinessNervous system disorders
FatigueGeneral disorders
Decreased appetiteMetabolism and nutrition disorders
Conjunctival haemorrhageEye disorders
DiplopiaEye disorders
Angle closure glaucomaEye disorders
BlepharitisEye disorders
Eye painEye disorders
Eyelid ptosisEye disorders
Macular fibrosisEye disorders
Vitreous haemorrhageEye disorders
Aspartate aminotransferase increasedInvestigations
Blood pressure increasedInvestigations
Blood thyroid stimulating hormone abnormalInvestigations
Blood thyroid stimulating hormone increasedInvestigations
Haemoglobin decreasedInvestigations
International normalised ratio decreasedInvestigations
International normalised ratio increasedInvestigations
Liver function test increasedInvestigations
Prostatic specific antigen increasedInvestigations
Renal function test abnormalInvestigations
Transaminases increasedInvestigations
Urinary Tract InfectionInfections and infestations
Gastroenteritis viralInfections and infestations
InfluenzaInfections and infestations
Respiratory tract infectionInfections and infestations
SinusitisInfections and infestations
VomitingGastrointestinal disorders
Abdominal discomfortGastrointestinal disorders
Abdominal painGastrointestinal disorders
ConstipationGastrointestinal disorders
DiarrhoeaGastrointestinal disorders
DysphagiaGastrointestinal disorders
Dizziness posturalNervous system disorders
HeadacheNervous system disorders
Tension headacheNervous system disorders
Muscle twitchingMusculoskeletal and connective tissue disorders

Most-reported serious reactions: Klebsiella bacteraemia, Systemic inflammatory response syndrome, Cerebellar artery thrombosis.

Data from ClinicalTrials.gov NCT01468844 adverse events section.

Sponsor's own description

Background: \- Central retinal vein occlusion (CRVO) is a blockage of the main vein that carries blood away from the retina in the back of the eye. It can lead to macular edema, a swelling of the retina that is a common source of vision loss. Studies suggest that inflammation might be a cause. Minocycline is a drug that might help prevent cells involved in inflammation from becoming activated. It is approved for use as an antibiotic, but it has not yet been tested to see if it can treat CRVO. Objectives: \- To test the safety and effectiveness of minocycline as a treatment for central retinal vein occlusion. Eligibility: \- Individuals at least 18 years of age who have central retinal vein occlusion in at least one eye, with vision between 20/32 and 20/200. Design: * This study lasts 2 years, with at least 25 visits. * Participants will be screened with a physical exam and medical history. They will also have blood tests and an eye exam. One eye will be selected as the study eye to receive the medicine. * Participants will take minocycline or a placebo pill twice a day, about 12 hours apart, for 2 years. * Participants will have monthly visits for blood tests and full eye exams to study the effect of the treatment. Other exams may include thyroid tests and eye imaging studies. Those in the study may also receive injections of a drug to prevent the growth of new blood vessels in the eye.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Oral minocycline for the treatment of diabetic macular edema (DME): results of a phase I/II clinical study.
    Cukras CA, Petrou P, Chew EY, Meyerle CB, et al · · 2012 · cited 70× · PMID 22589436 · DOI 10.1167/iovs.11-9413
  2. Adalimumab Reduces Photoreceptor Cell Death in A Mouse Model of Retinal Degeneration.
    Martínez-Fernández de la Cámara C, Hernández-Pinto AM, Olivares-González L, Cuevas-Martín C, et al · · 2015 · cited 49× · PMID 26170250 · DOI 10.1038/srep11764
  3. Modulation of the Immune System for the Treatment of Glaucoma.
    Bell K, Und Hohenstein-Blaul NVT, Teister J, Grus F. · · 2018 · cited 39× · PMID 28730968 · DOI 10.2174/1570159x15666170720094529
  4. Treatments for macular oedema following central retinal vein occlusion: systematic review.
    Ford JA, Clar C, Lois N, Barton S, et al · · 2014 · cited 19× · PMID 24513867 · DOI 10.1136/bmjopen-2013-004120

Verify or expand the search:

Other trials of Minocycline

Trials testing the same drug.

Other recruiting trials for Retinal Vein Occlusion

Currently open trials in the same condition.

Other National Eye Institute (NEI) trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01468844.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing