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Treatment of Macular Edema After Cataract Surgery With Subconjunctival Aflibercept (ACME)

Primary Purpose

Irvine-Gass Syndrome

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Aflibercept

About this trial

This is an interventional treatment trial for Irvine-Gass Syndrome focused on measuring macular edema, pseudophakia, pseudophakic macular edema, retinal swelling, aflibercept, anti-vascular endothelial growth factor, subconjunctival injection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.
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.

Sites / Locations

Tufts Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Subconjunctival aflibercept

Arm Description

Subconjunctival aflibercept 2 milligrams (mg) /0.05 milliliters (mL) administered at baseline visit and possibly again at Month 1 visit depending on initial response.

Outcomes

Primary Outcome Measures

Adverse Events

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

Secondary Outcome Measures

Change in visual acuity

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

Change in central retinal thickness

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

Proportion of patients needing re-treatment

Proportion of patients needing subconjunctival aflibercept injection treatment at Month 1

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

Adverse Events - end of study period

Incidence and severity of systemic and ocular events at Month 6

Full Information

NCT ID

NCT03396861

First Posted

January 5, 2018

Last Updated

August 19, 2020

Sponsor

Tufts Medical Center

Collaborators

Regeneron Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03396861

Brief Title

Treatment of Macular Edema After Cataract Surgery With Subconjunctival Aflibercept

Acronym

ACME

Official Title

Subconjunctival Aflibercept Injection for Pseudophakic Cystoid Macular Edema

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Terminated

Why Stopped

Low enrollment

Study Start Date

February 22, 2019 (Actual)

Primary Completion Date

August 18, 2019 (Actual)

Study Completion Date

January 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tufts Medical Center

Collaborators

Regeneron Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irvine-Gass Syndrome

Keywords

macular edema, pseudophakia, pseudophakic macular edema, retinal swelling, aflibercept, anti-vascular endothelial growth factor, subconjunctival injection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Subconjunctival aflibercept

Arm Type

Experimental

Arm Description

Subconjunctival aflibercept 2 milligrams (mg) /0.05 milliliters (mL) administered at baseline visit and possibly again at Month 1 visit depending on initial response.

Intervention Type

Drug

Intervention Name(s)

Aflibercept

Intervention Description

Subconjunctival aflibercept

Primary Outcome Measure Information:

Title

Adverse Events

Description

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

Time Frame

Month 2

Secondary Outcome Measure Information:

Title

Change in visual acuity

Description

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

Time Frame

Month 2 and Month 6

Title

Change in central retinal thickness

Description

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

Time Frame

Month 2 and Month 6

Title

Proportion of patients needing re-treatment

Description

Proportion of patients needing subconjunctival aflibercept injection treatment at Month 1

Time Frame

Month 1

Title

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

Description

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

Time Frame

Month 6

Title

Adverse Events - end of study period

Description

Incidence and severity of systemic and ocular events at Month 6

Time Frame

Month 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elias Reichel, MD

Organizational Affiliation

Tufts Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tufts Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26985802

Citation

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.

Results Reference

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PubMed Identifier

25438734

Citation

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.

Results Reference

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PubMed Identifier

18053911

Citation

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.

Results Reference

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PubMed Identifier

27617392

Citation

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.

Results Reference

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PubMed Identifier

16296723

Citation

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.

Results Reference

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PubMed Identifier

22634640

Citation

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.

Results Reference

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PubMed Identifier

22302382

Citation

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.

Results Reference

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PubMed Identifier

18356264

Citation

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.

Results Reference

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PubMed Identifier

27084563

Citation

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.

Results Reference

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Treatment of Macular Edema After Cataract Surgery With Subconjunctival Aflibercept

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