Pilot Study to Evaluate Oral Minocycline in the Treatment of Cystoid Macular Edema Associated with Retinitis Pigmentosa
Pilot Study to Evaluate Oral Minocycline in the Treatment of Cystoid Macular Edema Associated with Retinitis Pigmentosa
批准号:
10261210
负责人:
Catherine Cukras
金额:
$3.22万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
--
资助国家:
美国
项目状态:
未结题
起止时间:
至
关键词:
Adverse eventAffectAnimal ModelAntibioticsBilateralBlindnessCategoriesCell DeathCellsContralateralCystoid Macular EdemaDevelopmentDiseaseEnrollmentEtiologyEyeFDA approvedGenetic DiseasesImmuneInflammatoryInterventionLabelLettersMeasurementMeasuresMicrogliaMinocyclineOptical Coherence TomographyOralOutcomeParticipantPatientsPeripheralPharmaceutical PreparationsPhase I/II Clinical TrialPilot ProjectsProcessProductionRetinaRetinitis PigmentosaSafetyThickTimeVisionVisual AcuityVisual Fieldsconstrictionmaculamacular edemaneuroinflammationneuroprotectionopen labelprospectiveresponse
中文摘要
点击翻译按钮获取中文摘要
英文摘要
Cystoid macular edema (CME) is a common feature in retinitis pigmentosa (RP), affecting up to 1/3 of patients.
RP-associated CME has been related to retinal neuroinflammation and microglial activation.
Minocycline, a FDA-approved antibiotic, exerts off-label inhibition of microglial activation and decreases inflammatory factor production, and has been found to exert neuroprotection in RP animal models.
The objective of this study is to investigate the safety and possible efficacy of oral minocycline as a primary treatment for CME in RP.
A single-center, prospective, open-label Phase I/II clinical trial enrolled five participants with bilateral CME associated with RP.
One eye in each participant was assigned as the study eye and the contralateral eye as the fellow eye. Participants were followed monthly for 3 months off-drug and then administered oral minocycline 100 mg twice daily for 12 months.
Main outcome variables included:(1) changes in best corrected visual acuity (BCVA) and (2) changes in retinal central subfield thickness (CST) measured using spectral domain optical coherence tomography (SD-OCT) relative to mean pretreatment measurements.
The study drug was well tolerated and not associated with any significant adverse events.
No significant changes in mean BCVA were noted in either the study eye or the fellow eye (P>0.05 for all comparisons). Changes relative to baseline were <10 letters for all eyes.
Mean percentage changes in CST however decreased progressively with time on treatment. Considering all eyes (n = 10), a decrease in CST decrease at 6 and 12 months (p=0.63) and (p=0.03) respectively.
Minocycline administration over 12 months was associated with:
A small but progressive and significant decrease in mean central macular thickness.
No significant changes in mean visual acuity
No significant change in average microperimetry responses.
Further study is needed to determine whether minocycline is a potentially useful mode of intervention for macular edema in the setting of RP.
期刊论文(0)
专著(0)
科研奖励(0)
会议论文
Longitudinal Investigation of Dark Adaptation in Participants with AMD
-
批准号:8556871
-
项目类别:
-
资助金额:$13.64万
-
财政年份:--
-
负责人:Catherine Cukras
-
依托单位:
Eval. of Minocycline as a Microglia Inhibitor in Tx of CRVO and BRVO
-
批准号:8737681
-
项目类别:
-
资助金额:$15.84万
-
财政年份:--
-
负责人:Catherine Cukras
-
依托单位:
Longitudinal Investigation of Dark Adaptation in Participants with AMD
-
批准号:8737669
-
项目类别:
-
资助金额:$14.18万
-
财政年份:--
-
负责人:Catherine Cukras
-
依托单位:
Eval. of Minocycline as a Microglia Inhibitor in Tx of CRVO and BRVO
-
批准号:9155610
-
项目类别:
-
资助金额:$29.38万
-
财政年份:--
-
负责人:Catherine Cukras
-
依托单位:
Medical Retina Fellowship
-
批准号:9556041
-
项目类别:
-
资助金额:$16.8万
-
财政年份:--
-
负责人:Catherine Cukras
-
依托单位:
Pilot Study to Evaluate Oral Minocycline in the Treatment of Cystoid Macular Edema Associated with Retinitis Pigmentosa
-
批准号:9556040
-
项目类别:
-
资助金额:$5.51万
-
财政年份:--
-
负责人:Catherine Cukras
-
依托单位:
Genotype - phenotype Study of Patients with Plaquenil-induced Retinal Toxicity,
-
批准号:9556036
-
项目类别:
-
资助金额:$2.89万
-
财政年份:--
-
负责人:Catherine Cukras
-
依托单位:
Eval. of Minocycline as a Microglia Inhibitor in Tx of CRVO and BRVO
-
批准号:9556039
-
项目类别:
-
资助金额:$6.83万
-
财政年份:--
-
负责人:Catherine Cukras
-
依托单位:
Evaluation of Dextromethorphan as a Microglia Inhibitor in the treatment of DME
-
批准号:10020016
-
项目类别:
-
资助金额:$3.03万
-
财政年份:--
-
负责人:Catherine Cukras
-
依托单位:
Eval. of Minocycline as a Microglia Inhibitor in Tx of CRVO and BRVO
-
批准号:10020017
-
项目类别:
-
资助金额:$9.91万
-
财政年份:--
-
负责人:Catherine Cukras
-
依托单位:
An Investigation of Vitamin A Palmitate Supplementation in Patients withAMD and/or Reticular Pseudodrusen (RPD) and Delayed Dark Adaptation
-
批准号:10020044
-
项目类别:
-
资助金额:$5.51万
-
财政年份:--
-
负责人:Catherine Cukras
-
依托单位:
Medical Retina Fellowship
-
批准号:10706221
-
项目类别:
-
资助金额:$99.77万
-
财政年份:--
-
负责人:Catherine Cukras
-
依托单位:
Longitudinal Investigation of Dark Adaptation in Participants with AMD
-
批准号:10706119
-
项目类别:
-
资助金额:$26.96万
-
财政年份:--
-
负责人:Catherine Cukras
-
依托单位:
Adaptive Optics Imaging of Outer Retinal Diseases
-
批准号:10930546
-
项目类别:
-
资助金额:$1.92万
-
财政年份:--
-
负责人:Catherine Cukras
-
依托单位:
Evaluation of Dextromethorphan as a Microglia Inhibitor in the treatment of DME
-
批准号:8737680
-
项目类别:
-
资助金额:$12.06万
-
财政年份:--
-
负责人:Catherine Cukras
-
依托单位:
Eval. of Minocycline as a Microglia Inhibitor in Tx of CRVO and BRVO
-
批准号:8938360
-
项目类别:
-
资助金额:$12.61万
-
财政年份:--
-
负责人:Catherine Cukras
-
依托单位:
Eval. of Minocycline as a Microglia Inhibitor in Tx of Diabetic Macular Edema
-
批准号:9155595
-
项目类别:
-
资助金额:$6.11万
-
财政年份:--
-
负责人:Catherine Cukras
-
依托单位:
Genotype - phenotype Study of Patients with Plaquenil-induced Retinal Toxicity,
-
批准号:10706117
-
项目类别:
-
资助金额:$31.86万
-
财政年份:--
-
负责人:Catherine Cukras
-
依托单位:
Pilot Study to Evaluate Oral Minocycline in the Treatment of Cystoid Macular Edema Associated with Retinitis Pigmentosa
-
批准号:9796729
-
项目类别:
-
资助金额:$5.71万
-
财政年份:--
-
负责人:Catherine Cukras
-
依托单位:
Medical Retina Fellowship
-
批准号:10930602
-
项目类别:
-
资助金额:$107.01万
-
财政年份:--
-
负责人:Catherine Cukras
-
依托单位:
海外基金