Fuchs' Endothelial DystrophyPhase 2/3NCT04018417
Evaluation of Amphotericin B in Optisol-GS for Prevention of Post-Keratoplasty Fungal Infections.
A Phase 2/3 study testing Amphotericin B in people with Fuchs' Endothelial Dystrophy, run by Cornea Research Foundation of America at 1 site in United States.
Trial summary
With the increasing popularity of endothelial keratoplasty, a coincident increase in the rate of fungal infections post-keratoplasty has been seen in the United States. In this study, the eye bank will harvest pairs of donor corneas and randomize one cornea from each pair to be stored in Optisol-GS per Eye Bank… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fuchs' Endothelial Dystrophy
- What is being tested?
- Amphotericin B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2019to 3 Jul 2019
- Phase
- Phase 2/3
- 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
- Male or female at least 18 years of age and any race or ethnicity
- Scheduled to have Descemet membrane endothelial keratoplasty
Who cannot join
- History of glaucoma surgery in operative eye
- Known allergy or intolerance to amphotericin B
- Presence of anterior chamber intraocular lens
- Corneal stromal or epithelial dysfunction
- Presence of glaucoma defined as optic nerve damage as confirmed on Humphrey visual field testing or retinal nerve fiber layer analysis
- Presence of peripheral anterior synechiae
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-masked, Placebo-controlled Study of the Safety of Amphotericin 0.255 μg/mL in Optisol-GS
With the increasing popularity of endothelial keratoplasty, a coincident increase in the rate of fungal infections post-keratoplasty has been seen in the United States. In this study, the eye bank will harvest pairs of donor corneas and randomize one cornea from each pair to be stored in Optisol-GS per Eye Bank Association of America guidelines. The eye bank will add amphotericin B 0.255 μg/mL (antifungal) to the storage solution for the mate cornea. The study donor corneas will be assigned to participants who are scheduled to undergo Descemet membrane endothelial keratoplasty. The surgeons, participants, and evaluators will remain masked regarding the donor cornea storage solution assignment. The participants will be followed for 6 months.
- Conditions
- Fuchs' Endothelial Dystrophy
- Being tested
- Amphotericin B
- Medical subject headings
- Fuchs' Endothelial Dystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amphotericin BDrug
Drug concentration: 0.255 μg/mL
| Study group | Role | What they receive |
|---|---|---|
| Amphotericin B | Experimental | The eye bank will add amphotericin B 0.255 μg/mL to the Optisol-GS donor cornea storage solution. Receives: Drug: Amphotericin B |
| Control | No intervention | The donor cornea will be stored in Optisol-GS per the eye bank's standard procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial cell density
Central corneal endothelial cell density will be assessed by specular microscopy
Measured: 6 months
Secondary outcomes (1)
Incidence of post-keratoplasty fungal keratitis
The incidence of post-keratoplasty fungal keratitis will be assessed.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start3 Jul 2019
- Primary completion3 Jul 2019
- Study completion3 Jul 2019
Why it stopped: Reconsidered significance in light of newly published in vitro data.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Fuchs' Endothelial DystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornea Research Foundation of America
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francis W Price, Jr, MD, Principal investigator, Price Vision Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018417
- Sponsor's protocol ID
- 2019-005
- Status last verified
- Jul 2019
- First submitted
- 11 Jul 2019
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Aldave AJ, DeMatteo J, Glasser DB, Tu EY, Iliakis B, Nordlund ML, Misko J, Verdier DD, Yu F. Report of the Eye Bank Association of America medical advisory board subcommittee on fungal infection after corneal transplantation. Cornea. 2013 Feb;32(2):149-54. doi: 10.1097/ICO.0b013e31825e83bf.
PubMed 23051906Armitage WJ. Preservation of Human Cornea. Transfus Med Hemother. 2011;38(2):143-147. doi: 10.1159/000326632. Epub 2011 Mar 16.
PubMed 21566714Hassan SS, Wilhelmus KR; Medical Review Subcommittee of the Eye Bank Association of America. Eye-banking risk factors for fungal endophthalmitis compared with bacterial endophthalmitis after corneal transplantation. Am J Ophthalmol. 2005 Apr;139(4):685-90. doi: 10.1016/j.ajo.2004.12.016.
PubMed 15808165Hassan SS, Wilhelmus KR, Dahl P, Davis GC, Roberts RT, Ross KW, Varnum BH; Medical Review Subcommittee of the Eye Bank Association of America. Infectious disease risk factors of corneal graft donors. Arch Ophthalmol. 2008 Feb;126(2):235-9. doi: 10.1001/archophthalmol.2007.45.
PubMed 18268215Keyhani K, Seedor JA, Shah MK, Terraciano AJ, Ritterband DC. The incidence of fungal keratitis and endophthalmitis following penetrating keratoplasty. Cornea. 2005 Apr;24(3):288-91. doi: 10.1097/01.ico..0000138832.3486.70.
PubMed 15778600Merchant A, Zacks CM, Wilhelmus K, Durand M, Dohlman CH. Candidal endophthalmitis after keratoplasty. Cornea. 2001 Mar;20(2):226-9. doi: 10.1097/00003226-200103000-00026.
PubMed 11248837Doshi H, Pabon S, Price MO, Feng MT, Price FW Jr. Overview of Systemic Candida Infections in Hospital Settings and Report of Candida After DMEK Successfully Treated With Antifungals and Partial Graft Excision. Cornea. 2018 Aug;37(8):1071-1074. doi: 10.1097/ICO.0000000000001608.
PubMed 29634675Duncan K, Parker J, Hoover C, Jeng BH. The Effect of Light Exposure on the Efficacy and Safety of Amphotericin B in Corneal Storage Media. JAMA Ophthalmol. 2016 Apr;134(4):432-6. doi: 10.1001/jamaophthalmol.2016.0008.
PubMed 26914028Lopez RM, Ayestaran A, Pou L, Montoro JB, Hernandez M, Caragol I. Stability of amphotericin B in an extemporaneously prepared i.v. fat emulsion. Am J Health Syst Pharm. 1996 Nov 15;53(22):2724-7. doi: 10.1093/ajhp/53.22.2724.
PubMed 8931814
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-masked, Placebo-controlled Study of the Safety of Amphotericin 0.255 μg/mL in Optisol-GS
- ClinicalTrials.gov ID
- NCT04018417
- Acronym / sponsor ID
- 2019-005
- Conditions
- Fuchs' Endothelial Dystrophy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Reconsidered significance in light of newly published in vitro data.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cornea Research Foundation of AmericaUniversity, hospital or other
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- 3 Jul 2019 (actual)
- Study completion
- 3 Jul 2019 (actual)
- First posted
- 12 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With the increasing popularity of endothelial keratoplasty, a coincident increase in the rate of fungal infections post-keratoplasty has been seen in the United States. In this study, the eye bank will harvest pairs of donor corneas and randomize one cornea from each pair to be stored in Optisol-GS per Eye Bank Association of America guidelines. The eye bank will add amphotericin B 0.255 μg/mL (antifungal) to the storage solution for the mate cornea. The study donor corneas will be assigned to participants who are scheduled to undergo Descemet membrane endothelial keratoplasty. The surgeons, participants, and evaluators will remain masked regarding the donor cornea storage solution assignment. The participants will be followed for 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amphotericin B | Experimental | Drug: Amphotericin BThe eye bank will add amphotericin B 0.255 μg/mL to the Optisol-GS donor cornea storage solution. |
| Control | No intervention | –The donor cornea will be stored in Optisol-GS per the eye bank's standard procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female at least 18 years of age and any race or ethnicity
- Scheduled to have Descemet membrane endothelial keratoplasty
Key exclusion criteria (6 listed)
- History of glaucoma surgery in operative eye
- Known allergy or intolerance to amphotericin B
- Presence of anterior chamber intraocular lens
- Corneal stromal or epithelial dysfunction
- Presence of glaucoma defined as optic nerve damage as confirmed on Humphrey visual field testing or retinal nerve fiber layer analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amphotericin BDrug concentration: 0.255 μg/mL | Drug | Amphotericin B |
Primary outcome
Endothelial cell density
Time frame: 6 months
Central corneal endothelial cell density will be assessed by specular microscopy
1 secondary outcome
Incidence of post-keratoplasty fungal keratitis
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- Background: PubMed 23051906Aldave AJ, DeMatteo J, Glasser DB, Tu EY, Iliakis B, Nordlund ML, Misko J, Verdier DD, Yu F. Report of the Eye Bank Association of America medical advisory board subcommittee on fungal infection after corneal transplantation. Cornea. 2013 Feb;32(2):149-54. doi: 10.1097/ICO.0b013e31825e83bf.
- Background: PubMed 21566714Armitage WJ. Preservation of Human Cornea. Transfus Med Hemother. 2011;38(2):143-147. doi: 10.1159/000326632. Epub 2011 Mar 16.
- Background: PubMed 15808165Hassan SS, Wilhelmus KR; Medical Review Subcommittee of the Eye Bank Association of America. Eye-banking risk factors for fungal endophthalmitis compared with bacterial endophthalmitis after corneal transplantation. Am J Ophthalmol. 2005 Apr;139(4):685-90. doi: 10.1016/j.ajo.2004.12.016.
- Background: PubMed 18268215Hassan SS, Wilhelmus KR, Dahl P, Davis GC, Roberts RT, Ross KW, Varnum BH; Medical Review Subcommittee of the Eye Bank Association of America. Infectious disease risk factors of corneal graft donors. Arch Ophthalmol. 2008 Feb;126(2):235-9. doi: 10.1001/archophthalmol.2007.45.
- Background: PubMed 15778600Keyhani K, Seedor JA, Shah MK, Terraciano AJ, Ritterband DC. The incidence of fungal keratitis and endophthalmitis following penetrating keratoplasty. Cornea. 2005 Apr;24(3):288-91. doi: 10.1097/01.ico..0000138832.3486.70.
- Background: PubMed 11248837Merchant A, Zacks CM, Wilhelmus K, Durand M, Dohlman CH. Candidal endophthalmitis after keratoplasty. Cornea. 2001 Mar;20(2):226-9. doi: 10.1097/00003226-200103000-00026.
- Background: PubMed 29634675Doshi H, Pabon S, Price MO, Feng MT, Price FW Jr. Overview of Systemic Candida Infections in Hospital Settings and Report of Candida After DMEK Successfully Treated With Antifungals and Partial Graft Excision. Cornea. 2018 Aug;37(8):1071-1074. doi: 10.1097/ICO.0000000000001608.
- Background: PubMed 26914028Duncan K, Parker J, Hoover C, Jeng BH. The Effect of Light Exposure on the Efficacy and Safety of Amphotericin B in Corneal Storage Media. JAMA Ophthalmol. 2016 Apr;134(4):432-6. doi: 10.1001/jamaophthalmol.2016.0008.
- Background: PubMed 8931814Lopez RM, Ayestaran A, Pou L, Montoro JB, Hernandez M, Caragol I. Stability of amphotericin B in an extemporaneously prepared i.v. fat emulsion. Am J Health Syst Pharm. 1996 Nov 15;53(22):2724-7. doi: 10.1093/ajhp/53.22.2724.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francis W Price, Jr, MD principal investigator
Price Vision Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Amphotericin B in people with Fuchs' Endothelial Dystrophy, run by Cornea Research Foundation of America 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 2 inclusion and 6 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: withdrawn, as of the sponsor's last update on 12 Jul 2019. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 withdrawn before enrolling participants, so there are no results.
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?
Endothelial cell density (time frame: 6 months). 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 NCT04018417, 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 12 Jul 2019.