Evidence map›Paper›PMID 36882562›Full record

Trial reportGraefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie2023

Oral minocycline for the treatment of retinitis pigmentosa-associated cystoid macular edema: results of a phase I/II clinical trial.

Amisha D Dave, Katherine G Chen, Trent Tsun-Kang Chiang, Janani Singaravelu, Jason A Alvarez, Wai T Wong, Catherine A Cukras

Registry-linked trialAbstract readClinical Trial, Phase IIClinical Trial, Phase I
PubMed Publisher
In one paragraph

Trial report in Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02140164 (Pilot Study to Evaluate Oral Minocycline in the Treatment of Cystoid Macular Edema Associated With Retinitis Pigmentosa), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
2.2field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02140164 phase1 / phase2completednot on this map

Pilot Study to Evaluate Oral Minocycline in the Treatment of Cystoid Macular Edema Associated With Retinitis Pigmentosa

TypeinterventionalSponsorNational Eye Institute (NEI)Ran2014 to 2016Enrolled7ConditionsRetinitis PigmentosaArmsMinocycline
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Article
  3. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 1 institution in 1 country.

Amisha D DaveNational Eye Institute, NIH, Bethesda, MD, 20892, USA.
Katherine G ChenNational Eye Institute, NIH, Bethesda, MD, 20892, USA.
Trent Tsun-Kang ChiangNational Eye Institute, NIH, Bethesda, MD, 20892, USA.
Janani SingaraveluNational Eye Institute, NIH, Bethesda, MD, 20892, USA.
Jason A AlvarezNational Eye Institute, NIH, Bethesda, MD, 20892, USA.
Wai T WongNational Eye Institute, NIH, Bethesda, MD, 20892, USA.
Catherine A CukrasUnit On Clinical Investigation of Retinal Disease, Division of Epidemiology and Clinical Research, National Eye Institute, National Institute of Health, Bethesda, MD, 20892, USA. cukrasc@nei.nih.gov.
National Eye Institute · US

Funding

Pilot Study to Evaluate Oral Minocycline in the Treatment of Cystoid Macular Edema Associated with Retinitis PigmentosaZIAEY000543 · NEI · NATIONAL EYE INSTITUTE · PI CUKRAS, CATHERINE · 2014 to 2025
$520k
6 · The paper itself

Abstract

purposeThe etiology of retinitis pigmentosa (RP)-associated cystoid macular edema (CME) has been related to retinal neuroinflammation and microglial activation. Minocycline, a drug FDA-approved for anti-microbial indications, also inhibits microglial activation and expression of inflammatory mediators. This study investigates the safety and efficacy of oral minocycline as primary treatment for RP-associated CME.

methodsA single-center, prospective, open-label phase I/II clinical trial enrolled five participants with RP-associated CME. Participants had lead-in assessments prior to the initiation of oral minocycline 100 mg twice daily for 12 months. Main outcome variables included changes in best-corrected visual acuity (BCVA) and retinal central subfield thickness (CST) measured using spectral domain optical coherence tomography relative to mean of pre-treatment measurements.

resultsThe study drug was well tolerated and not associated with any severe adverse events. No significant changes in mean BCVA from study baseline were noted in either the study eye (+ 0.7 ± 4.1 letters at 6 months, - 1.1 ± 1.7 letters at 12 months) or the qualifying fellow eye (- 0.3 ± 3.4 letters at 6 months, - 0.3 ± 4.6 letters at 12 months) (p > 0.05 for all comparisons). Mean percentage changes in CST from baseline however decreased progressively with treatment (decreases at 6 and 12 months: study eyes 3.9 and 9.8%; qualifying fellow eyes 1.4 and 7.7%). Considering all eyes (n = 10), mean percentage CST decrease at 6 and 12 months was 2.7 ± 9.5% (p = 0.39) and 8.7 ± 9.5% (p = 0.02) respectively.

conclusionOral minocycline administration over 12 months was associated with no significant changes in mean BCVA and a small but progressive decrease in mean CST.

trial registrationNCT02140164 (05/2014).

Indexed as

Macular EdemaRetinitis PigmentosaHumansMinocyclineProspective StudiesRetinaTomography, Optical CoherenceMinocyclineCystoid macular edemaMinocyclineOCTRetinitis pigmentosa

Identifiers

PMID36882562
OpenAlexW4323535352

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.