AzTrials
AzTrials

Epiretinal MembraneNCT05416827

Evaluation of Intraoperative Slow-release Dexamethasone Implant for Epiretinal Membrane

A study testing slow-release dexamethasone implant in people with Epiretinal Membrane, run by Peking University People's Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Epiretinal membrane (ERM) is a commonly encountered vitreoretinal interface anomaly with a prevalence of approximately 10% in the adult population. It is often treated with pars plana vitrectomy (PPV) and membrane peeling when symptomatic. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Epiretinal Membrane
What is being tested?
slow-release dexamethasone implant
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
15 Jun 2022to 15 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients with a visually significant (BCVA<20/50) idiopathic epiretinal membrane.
  • ocular axial length less than 27.00 mm (optical biometry) associated with cataracts.

Who cannot join

  • concomitant or previous macular diseases (diabetic macular edema, retinal vein occlusion and agerelated macular degeneration).
  • secondary epiretinal membrane, other visually significant macular pathology and prior intravitreal triamcinolone acetonide injection.

Trial locations and contacts

No sites are listed yet.

Jinfeng Qu, MD contact

+861088326666

Jinfeng_QuPKU@163.com

About this study

Official title: Evaluation of Intraoperative Slow-release Dexamethasone Implant Used During Vitrectomy for Epiretinal Membrane

Epiretinal membrane (ERM) is a commonly encountered vitreoretinal interface anomaly with a prevalence of approximately 10% in the adult population. It is often treated with pars plana vitrectomy (PPV) and membrane peeling when symptomatic. PPV is generally successful at improving visual acuity (VA) and/or metamorphopsia. At times, however, visual recovery can be hindered by macular edema in the post-vitrectomy period. Ozurdex can accelerate the resorption of intraretinal edema and hasten the improvement in the visual acuity. It has been shown to facilitate fluid absorption by both stimulating endogenous adenosine signaling in Muller cells and by down regulating vascular endothelial growth factor production. So, this study aim to investigate the efficacy of Ozurdex implant after PPV in epiretinal membrane eyes.

Read the detailed description

Small gauge pars plana vitrectomy (PPV) with membrane peeling is used to successfully treat macular epiretinal membranes (ERMs) with a postoperative improvement of visual acuity in the majority of cases. Traditionally, the treatment of ERMs has been performed purely by peeling the membrane mechanically and then waiting for the intraretinal edema to resolve spontaneously. In the last few years, some publications raised the possibility that triamcinolone acetonide (TA),given as an intravitreal injection at the end of surgery, can accelerate the resorption of intraretinal edema and hasten the improvement in the visual acuity. It has been shown to facilitate fluid absorption by both stimulating endogenous adenosine signaling in Muller cells and by down regulating vascular endothelial growth factor production. Dexamethasone is a potent synthetic member of the glucocorticoid class of steroid drugs that has anti-inflammatory and immunosuppressant activity 30 times that of cortisol and 6 times that of triamcinolone. As the postoperative cystoid macular edema usually peaks 4 to 6 weeks after surgery the difference in the half life can be significant and explained the results in past publications. While the use of intravitreal TA as an adjuvant to PPV with membrane peel showed conflicting results. Only few publications demonstrated the effectiveness of Ozurdex in the treatment of macular edema in a vitrectomized eye, after ERM removal.So, this study aim to investigate the efficacy of Ozurdex implant after PPV in epiretinal membrane eyes.

Being tested
slow-release dexamethasone implant
Keywords
Epiretinal Membrane; Ozurdex; PPV
Medical subject headings
Epiretinal Membrane

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • slow-release dexamethasone implantProcedure or surgery

    Epiretinal membrane eyes underwent PPV combined with Ozurdex implant

Study groups in NCT05416827
Study groupRoleWhat they receive
PPV groupActive comparatorEpiretinal membrane eyes underwent PPV
Receives: Procedure: slow-release dexamethasone implant
PPV+implant GroupExperimentalEpiretinal membrane eyes underwent PPV combined with Ozurdex implant
Receives: Procedure: slow-release dexamethasone implant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CMT

    central macular thickness

    Measured: from preoperation to 3 months follow-up

  2. IOP

    intraocular pressure

    Measured: from preoperation to 3 months follow-up

  3. BCVA

    best-corrected visual acuity

    Measured: from preoperation to 3 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2022
  2. Study start15 Jun 2022 (estimated)
  3. Primary completion15 Sep 2022 (estimated)
  4. Study completion15 Sep 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05416827
Sponsor's protocol ID
PKUPHophthal
Status last verified
Jun 2022
First submitted
9 Jun 2022
Last updated
13 Jun 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Reilly G, Melamud A, Lipscomb P, Toussaint B. SURGICAL OUTCOMES IN PATIENTS WITH MACULAR PUCKER AND GOOD PREOPERATIVE VISUAL ACUITY AFTER VITRECTOMY WITH MEMBRANE PEELING. Retina. 2015 Sep;35(9):1817-21. doi: 10.1097/IAE.0000000000000558.

    PubMed 25923959

  • Mao J, Xu Z, Lao J, Chen Y, Xu X, Wu S, Zheng Z, Liu B, Shen L. Assessment of macular microvasculature features before and after vitrectomy in the idiopathic macular epiretinal membrane using a grading system: An optical coherence tomography angiography study. Acta Ophthalmol. 2021 Nov;99(7):e1168-e1175. doi: 10.1111/aos.14753. Epub 2021 Jan 10.

    PubMed 33423352

  • Yang HS, Kim JT, Joe SG, Lee JY, Yoon YH. Postoperative restoration of foveal inner retinal configuration in patients with epiretinal membrane and abnormally thick inner retina. Retina. 2015 Jan;35(1):111-9. doi: 10.1097/IAE.0000000000000276.

    PubMed 25102192

  • Beer PM, Bakri SJ, Singh RJ, Liu W, Peters GB 3rd, Miller M. Intraocular concentration and pharmacokinetics of triamcinolone acetonide after a single intravitreal injection. Ophthalmology. 2003 Apr;110(4):681-6. doi: 10.1016/S0161-6420(02)01969-3.

    PubMed 12689886

  • Chin HS, Park TS, Moon YS, Oh JH. Difference in clearance of intravitreal triamcinolone acetonide between vitrectomized and nonvitrectomized eyes. Retina. 2005 Jul-Aug;25(5):556-60. doi: 10.1097/00006982-200507000-00002.

    PubMed 16077349

  • Medeiros MD, Alkabes M, Navarro R, Garcia-Arumi J, Mateo C, Corcostegui B. Dexamethasone intravitreal implant in vitrectomized versus nonvitrectomized eyes for treatment of patients with persistent diabetic macular edema. J Ocul Pharmacol Ther. 2014 Nov;30(9):709-16. doi: 10.1089/jop.2014.0010. Epub 2014 Sep 26.

    PubMed 25259834

  • Boyer DS, Faber D, Gupta S, Patel SS, Tabandeh H, Li XY, Liu CC, Lou J, Whitcup SM; Ozurdex CHAMPLAIN Study Group. Dexamethasone intravitreal implant for treatment of diabetic macular edema in vitrectomized patients. Retina. 2011 May;31(5):915-23. doi: 10.1097/IAE.0b013e318206d18c.

    PubMed 21487341

  • Li S, Zeng Q, Zhu L, Liu W, Li Y, Li J, Li X, Zhao M, Qu J. Intraoperative slow-release dexamethasone intravitreal implant (Ozurdex) in epiretinal membrane peeling surgery: a prospective randomized controlled trial. Front Pharmacol. 2023 Sep 1;14:1219861. doi: 10.3389/fphar.2023.1219861. eCollection 2023.

    PubMed 37727387

Questions about this trial

What is this clinical trial studying?

A study testing slow-release dexamethasone implant in people with Epiretinal Membrane, run by Peking University People's Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jinfeng Qu, MD (+861088326666, Jinfeng_QuPKU@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CMT (time frame: from preoperation to 3 months follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05416827, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2022; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in