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Irvine-Gass SyndromePhase 1ACMENCT03396861

Treatment of Macular Edema After Cataract Surgery with Subconjunctival Aflibercept

A Phase 1 study testing Aflibercept in people with Irvine-Gass Syndrome, run by Tufts Medical Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This research study is being conducted to determine the safety and tolerability of subconjunctival injections of aflibercept in the treatment of pseudophakic cystoid macular edema that has not responded well to first-line standard of care treatment (eye drops). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Irvine-Gass Syndrome
What is being tested?
Aflibercept
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteUnited States
Study dates
22 Feb 2019to 2 Jan 2020
Phase
Phase 1
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

  • Diagnosed with pseudophakic CME defined as central retinal thickness (CRT)>300 microns, presence of intraretinal cysts on optical coherence tomography (OCT) and visual acuity <=20/32 with petaloid leakage on fluorescein angiogram and late leakage at the disc
  • Diagnosed with "recalcitrant" CME, defined as less than a 15% decrease in CRT after at least 6 weeks of topical non-steroidal anti-inflammatory drug
  • Has had cataract surgery in the study eye with posterior chamber or anterior chamber intraocular lens implantation
  • Willing and able to comply with clinic visits and study-related procedures
  • Provide signed informed consent

Who cannot join

  • Retinal diseases (including diabetic retinopathy, retinal vein or artery occlusion, neovascular age-related macular degeneration, radiation retinopathy, vitreomacular traction, epiretinal membrane).
  • Active intraocular inflammation (grade trace or above) in the study eye, or history of idiopathic or autoimmune-associated uveitis in either eye.
  • Active infectious conjunctivitis, keratitis, scleritis or endophthalmitis in either eye.
  • Prior treatment with sub-Tenon's or intravitreal steroids.
  • Prior treatment with an intravitreal anti-vascular endothelial growth factor (VEGF) agent in the study eye or systemic administration of anti-VEGF.
  • Use of topical prostaglandin analogues or pilocarpine.
Show all 15Show fewer
  • Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with glaucoma medications.
  • Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye.
  • Vision loss in the study eye, determined by the investigator to be from a cause other than CME, e.g. optic neuropathy, end-stage glaucoma.
  • Any significant media opacity including vitreous hemorrhage or corneal scarring.
  • Fluorescein dye allergy or intolerance
  • Allergy to aflibercept or any of the components
  • Cerebrovascular accident or myocardial infarction within 1 year of the screening visit.
  • Pregnant or breast-feeding women
  • Sexually active men or women of childbearing potential who are unwilling to practice adequate contraception starting at least 2 menstrual cycles prior to the baseline visit, during the study and in the 3 months immediately following the last dose of study drug.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Tufts Medical Center

    Boston, Massachusetts, 02111

Other trials in United States

About this study

Official title: Subconjunctival Aflibercept Injection for Pseudophakic Cystoid Macular Edema

This research study is being conducted to determine the safety and tolerability of subconjunctival injections of aflibercept in the treatment of pseudophakic cystoid macular edema that has not responded well to first-line standard of care treatment (eye drops).

Pseudophakic cystoid macular edema (CME) is swelling of the retina that can occur weeks or years after cataract surgery and typically results in decreased vision. Subconjunctival injections are injections placed just beneath the clear membrane (conjunctiva) of the eye.

A recent report of one patient who received two subconjunctival injections of a similar medication to the one being studied here indicated that subconjunctival injections of this class of medication may be an effective and less invasive alternative to intravitreal injections for pseudophakic CME. Because of the similarity of the drugs and the patient's treatment success, we would like to see if subconjunctival injection(s) of aflibercept will work in treating pseudophakic CME. If successful, the risk of an intraocular infection and glaucoma that comes with standard of care treatments might be greatly reduced.

Being tested
Aflibercept
Keywords
macular edema, pseudophakia, pseudophakic macular edema, retinal swelling, aflibercept, anti-vascular endothelial growth factor, subconjunctival injection
Medical subject headings
Macular Edema, Pseudophakia

What participants receive

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

  • AfliberceptDrug

    Subconjunctival aflibercept

Study groups in NCT03396861
Study groupRoleWhat they receive
Subconjunctival afliberceptExperimentalSubconjunctival aflibercept 2 milligrams (mg) /0.05 milliliters (mL) administered at baseline visit and possibly again at Month 1 visit depending on initial response.
Receives: Drug: Aflibercept

What is being measured

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

  1. Adverse Events

    Systemic and ocular adverse events of subconjunctivally administered aflibercept injection in the treatment of pseudophakic cystoid macular edema at Month 2

    Measured: Month 2

Secondary outcomes (5)

  1. Change in visual acuity

    Change in best-corrected visual acuity at Months 2 and 6

    Measured: Month 2 and Month 6

  2. Change in central retinal thickness

    Change in central retinal thickness as measured by optical coherence tomography at Months 2 and 6

    Measured: Month 2 and Month 6

  3. Proportion of patients needing re-treatment

    Proportion of patients needing subconjunctival aflibercept injection treatment at Month 1

    Measured: Month 1

  4. Proportion of patients needing additional non-study treatment though Month 6

    Proportion of patients receiving additional non-study treatment (e.g. periocular or intravitreal steroid) through Month 6

    Measured: Month 6

  5. Adverse Events - end of study period

    Incidence and severity of systemic and ocular events at Month 6

    Measured: Month 6

Timeline

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

  1. First posted11 Jan 2018
  2. Study start22 Feb 2019
  3. Primary completion18 Aug 2019
  4. Study completion2 Jan 2020

Why it stopped: Low enrollment

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03396861
Sponsor's protocol ID
12338
Acronym
ACME
Status last verified
Oct 2024
First submitted
5 Jan 2018
Last updated
15 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Muakkassa NW, Klein KA, Hamrah P, Reichel E. Subconjunctival Bevacizumab for the Treatment of Keratoprosthesis-Associated Cystoid Macular Edema. Ophthalmic Surg Lasers Imaging Retina. 2016 Mar;47(3):276-9. doi: 10.3928/23258160-20160229-11.

    PubMed 26985802

  • Guo S, Patel S, Baumrind B, Johnson K, Levinsohn D, Marcus E, Tannen B, Roy M, Bhagat N, Zarbin M. Management of pseudophakic cystoid macular edema. Surv Ophthalmol. 2015 Mar-Apr;60(2):123-37. doi: 10.1016/j.survophthal.2014.08.005. Epub 2014 Sep 2.

    PubMed 25438734

  • Arevalo JF, Garcia-Amaris RA, Roca JA, Sanchez JG, Wu L, Berrocal MH, Maia M; Pan-American Collaborative Retina Study Group. Primary intravitreal bevacizumab for the management of pseudophakic cystoid macular edema: pilot study of the Pan-American Collaborative Retina Study Group. J Cataract Refract Surg. 2007 Dec;33(12):2098-105. doi: 10.1016/j.jcrs.2007.07.046.

    PubMed 18053911

  • Lin CJ, Tsai YY. USE OF AFLIBERCEPT FOR THE MANAGEMENT OF REFRACTORY PSEUDOPHAKIC MACULAR EDEMA IN IRVINE-GASS SYNDROME AND LITERATURE REVIEW. Retin Cases Brief Rep. 2018 Winter;12(1):59-62. doi: 10.1097/ICB.0000000000000414.

    PubMed 27617392

  • Raghava S, Hammond M, Kompella UB. Periocular routes for retinal drug delivery. Expert Opin Drug Deliv. 2004 Nov;1(1):99-114. doi: 10.1517/17425247.1.1.99.

    PubMed 16296723

  • Bahar I, Yeung SN, Sella R, Slomovic A. Anterior segment uses of bevacizumab. Curr Opin Ophthalmol. 2012 Jul;23(4):303-16. doi: 10.1097/ICU.0b013e3283548459.

    PubMed 22634640

  • Papadopoulos N, Martin J, Ruan Q, Rafique A, Rosconi MP, Shi E, Pyles EA, Yancopoulos GD, Stahl N, Wiegand SJ. Binding and neutralization of vascular endothelial growth factor (VEGF) and related ligands by VEGF Trap, ranibizumab and bevacizumab. Angiogenesis. 2012 Jun;15(2):171-85. doi: 10.1007/s10456-011-9249-6.

    PubMed 22302382

  • Stewart MW, Rosenfeld PJ. Predicted biological activity of intravitreal VEGF Trap. Br J Ophthalmol. 2008 May;92(5):667-8. doi: 10.1136/bjo.2007.134874. Epub 2008 Mar 20.

    PubMed 18356264

  • Kitchens JW, Do DV, Boyer DS, Thompson D, Gibson A, Saroj N, Vitti R, Berliner AJ, Kaiser PK. Comprehensive Review of Ocular and Systemic Safety Events with Intravitreal Aflibercept Injection in Randomized Controlled Trials. Ophthalmology. 2016 Jul;123(7):1511-20. doi: 10.1016/j.ophtha.2016.02.046. Epub 2016 Apr 12.

    PubMed 27084563

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Aflibercept in people with Irvine-Gass Syndrome, run by Tufts Medical Center at 1 site in United States.

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 5 inclusion and 15 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: stopped early, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Low enrollment). Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (time frame: Month 2). 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 NCT03396861, which also lists 9 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 15 Oct 2024.

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