| CTRI Number |
CTRI/2023/02/049356 [Registered on: 01/02/2023] Trial Registered Prospectively |
| Last Modified On: |
31/01/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
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Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Study to Assess the Effectiveness of Two Concentrations of STN1010904 Ophthalmic Suspension Compared with Inert vehicle in Participants diagnosed with Fuchs Endothelial Corneal Dystrophy (FECD) |
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Scientific Title of Study
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A Phase IIa, Randomized, Double-masked, Placebo-Controlled, Parallel-Group,
Multicenter Study Assessing the Efficacy and Safety of STN1010904 Ophthalmic Suspension 0.03% and 0.1% Compared with Vehicle in Subjects with Fuchs Endothelial Corneal Dystrophy
(FECD)– PHANTOM Study |
| Trial Acronym |
PHANTOM Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 101090401IN |
Protocol Number |
| 2022-000174-25 |
EudraCT |
| NCT05376176 |
ClinicalTrials.gov |
| Original Version Dated 24NOV2021 |
Other |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Jyoti Puri |
| Designation |
Medical Director |
| Affiliation |
Syneos Health |
| Address |
inVentiv International Pharma Services Pvt Ltd., 4th and 5th Floor, Block-2, DLF Downtown, Commercial Site, Block-V, DLF City, Phase III, Sector-25A, Gurugram – 122002
Gurgaon
HARYANA
122002
India |
| Phone |
7303111499 |
| Fax |
|
| Email |
jyoti.puri@syneoshealth.com |
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Details of Contact Person
Public Query
|
| Name |
Jignesh Patel |
| Designation |
Clinical Trial Manager |
| Affiliation |
Syneos Health |
| Address |
Building No. 4 & No.1, Commerzone IT park, Yerwada, Pune- 411006, India
Pune
MAHARASHTRA
411006
India |
| Phone |
9824666773 |
| Fax |
|
| Email |
Jignesh.patel@syneoshealth.com |
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Source of Monetary or Material Support
|
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Primary Sponsor
|
| Name |
Santen Incorporated |
| Address |
6401 Hollis Street, Suite 125, Emeryville, CA 94608 |
| Type of Sponsor |
Pharmaceutical industry-Global |
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Details of Secondary Sponsor
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| Name |
Address |
| InVentiv International Pharma Services Pvt Ltd |
InVentiv International Pharma Services Pvt Ltd.,
3rd Floor, Tower B, 46/4, Presidency Tower MG Road,
Sector 14, Gurgaon Gurgaon (India) – 122001. |
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Countries of Recruitment
|
France
India
United States of America |
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Sites of Study
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| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prema Padmanabhan |
Sankara Nethralaya (A Unit of Medical Research Foundation) |
Department of Cornea and Refractive surgery
41/18, College Road, Chennai.600006
Chennai
TAMIL NADU |
4428271616
dr.premapad@gmail.com |
| Dr Sunita Chaurasia |
Suven Clinical Research Center |
L V Prasad Eye Institute, Kallam Anji Reddy Campus, L V Prasad Marg.
Hyderabad
TELANGANA |
4068102124
sunita@lvpei.org |
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Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics Committee- L V Prasad Eye Institute |
Submittted/Under Review |
| Institutional Review Board (Ethics Committee) |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H184||Corneal degeneration, |
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.03% STN1010904 ophthalmic suspension |
Topical ocular, one drop twice daily from Visit 2 (Baseline) to
Visit 9 (Month 18). |
| Intervention |
0.1% STN1010904 ophthalmic suspension |
Topical ocular, one drop twice daily from Visit 2 (Baseline) to
Visit 9 (Month 18). |
| Comparator Agent |
Placebo (Vehicle) |
Topical ocular, one drop twice daily from Visit 2 (Baseline) to
Visit 9 (Month 18). |
|
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1) Male or female, from 30 to 75 years of age, diagnosed with FECD
2) Provide signed informed consent prior to any study procedures being performed
3) Best-corrected visual acuity (BCVA) of plus 0.2 LogMAR or better (equivalent to greater than or equal to 75 Early Treatment Diabetic Retinopathy Study [ETDRS] letters, or at least Snellen 20/32) in the study eye as measured using an ETDRS chart
4) Grade 3-5 of the Modified Krachmer scale in the study eye
5) At least two out of three tomographic features (Loss of parallel isopachs/ Displacement of the thinnest point of the cornea/ Focal posterior corneal depression) are observed by Pentacam, evaluated by the Investigator in the study eye
6) Endothelial cells are visible greater than 50 percent of area in at least one image obtained by noncontact specular microscopy in the central or paracentral-peripheral area in the study eye.
7) If a subject is a female of childbearing potential (that is, not post-menopausal [within 12 months since the last menses] or not surgically sterile [less than 6 months from date of surgery]), she must have a negative urine pregnancy test and must use at least one of the acceptable contraceptive methods during the study
8) The male partner of the female subject of childbearing potential should use or practice an acceptable contraceptive method, such as abstinence, condom or vasectomy (surgery at least 6 months prior to signing the study informed consent form (ICF) and beginning screening), or other contraception deemed adequate by the investigator during the study
9) Male subjects, with a female partner of childbearing potential, should use or practice an acceptable contraceptive method, such as abstinence, condom or vasectomy (surgery at least 6 months prior to signing the study ICF), or other contraception deemed adequate by the investigator during the study
10)Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
|
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| ExclusionCriteria |
| Details |
1) Monocular vision, or vision worse than plus 0.7 LogMAR (equivalent to less than 50 ETDRS letters, or worse than Snellen 20/100) in the fellow eye
2) No guttae in either eye (evaluated by slit lamp and specular microscope)
3) Clinically evident stromal and/or epithelial edema in the study eye (evaluated by slit lamp microscope)
4) Descemet folds in the study eye (evaluated by slit lamp microscope)
5) Central cornea thickness is 630μm or more in the study eye (evaluated by Scheimpflug image)
6) Moderate/severe cataract in the study eye (mild cataract or pseudophakic eye is eligible for enrolment)
7) Evidence of any other ocular disease other than FECD in the study eye that may confound the outcome of the study (example, active diabetic retinopathy, posterior uveitis, age-related macular degeneration or any other maculopathy, severe myopia greater than 10D, pterygium).
8) Any ocular surgery for FECD (e.g., penetrating keratoplasty (PKP), Descemet stripping endothelial keratoplasty (DSEK), Descemet membrane endothelial keratoplasty (DMEK), Descemet stripping automated endothelial keratoplasty (DSAEK), Descemet stripping only (DSO) in the study eye
9) Cataract surgery or any kind of ocular surgery in the study eye within 6 months prior to Visit 1
10) Past history of filtering surgery for glaucoma in either eye (patients who underwent Minimally Invasive Glaucoma Surgery (MIGS) more than 6 months prior to Visit 1 are eligible for enrolment)
11) Laser treatment for glaucoma within 6 months prior to Visit 1 in the study eye
12) Need for ocular surgery or ocular laser treatment in either eye throughout the study
13) Media opacity that would affect contrast sensitivity in the study eye
14) Presence of any active inflammation, or infection of the eye and/or eyelids in either eye
15) History of herpetic infection in either eye or adnexa
16) Use of Rho-Associated kinase (ROCK) inhibitor eye drop in the study eye within 4 weeks prior to Visit 1 and during the course of the study
17) Use of CYP3A strong inhibitors during the course of the study
18) Use of topical Cyclosporin within 3 months prior to Visit 1 and during the course of the study
19) Use of Xiidra within 1 month prior to Visit 1 and during the course of the study
20) Allergy or hypersensitivity to study drug product, fluorescein dye, or other study related procedures/medications
21) Current or planned participation in any other clinical study involving an investigational product or device within 4 weeks prior to Visit 1 or at any time during this study
22) History of any disease or condition that in the opinion of the study investigator may put the subject at significant risk, may confound study results, or may interfere significantly with the subject’s participation in the study
23) Immunosuppressive therapy (e.g., methotrexate, cyclosporine, cyclophosphamide, chlorambucil, mycophenolate mofetil, tacrolimus or azathioprine) other than prednisone or other corticosteroids within 4 weeks prior to Visit 1 or at any time during this study
24) Any recent systemic infection within 4 weeks prior to Visit 1
25) Known to be immunocompromised
26) History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease condition that contraindicates the use of an investigational drug, might affect the interpretation of the results of the study, or renders the subject at high risk for treatment complications
27) History of ophthalmic malignancy
28) Malignancy in remission for less than 5 years prior to study participation
29) Females who are pregnant or lactating and females of child-bearing potential who are not willing to use acceptable contraceptive methods during the study and for 4 weeks following the last dose
30) Any decision by the Investigator or Medical Monitor to terminate a subject in screening or declare any subject ineligible for any sound medical reason
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Method of Generating Random Sequence
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Permuted block randomization, fixed |
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Method of Concealment
|
Centralized |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
1. Change From Baseline in Best Corrected Visual Acuity (BCVA) with 100% Contrast Level
2. Change From Baseline in BCVA With 10 % Contrast Level
3. Change From Baseline in Contrast Sensitivity With Glare Light
|
Baseline, Month 18 |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Best Corrected Visual Acuity (BCVA) with Contrast Level of 100 Percent at All Post-baseline Visits |
Up to month 18 |
BCVA with Contrast Level of 10 Percent at All Post-baseline
visits |
Up to month 18 |
Contrast Sensitivity with Glare Light at All Post-baseline
Visits |
Up to month 18 |
Contrast Sensitivity Without Glare Light at All Post-baseline
visits |
Up to month 18 |
Change From Baseline in BCVA With 100 Percent Contrast Level at All Post-baseline
Visits |
Up to month 18 |
| Percent Change From Baseline in BCVA With 100 Percent Contrast Level at All Post-Baseline Visits |
Up to month 18 |
| Change From Baseline in BCVA With 10 Percent Contrast Level at All Post-baseline Visits |
Up to month 18 |
| Percent Change From Baseline in BCVA With 10 Percent Contrast Level at All Post-baseline Visits |
Up to month 18 |
| Change From Baseline in Contrast Sensitivity With Glare Light at All Post-baseline Visits |
Up to month 18 |
| Percent Change From Baseline in Contrast Sensitivity With Glare Light at All Post-baseline Visits |
Up to month 18 |
| Change From Baseline in Contrast Sensitivity Without Glare Light at All Post-Baseline visits |
Up to month 18 |
| Percent Change From Baseline in Contrast Sensitivity Without Glare Light at All Post-baseline Visits |
Up to month 18 |
Change From Baseline in Central Corneal Thickness at All Post-baseline
Visits |
Up to month 18 |
Percent Change From Baseline in Central Corneal Thickness at All Post-baseline
Visits |
Up to month 18 |
Change From Baseline in Endothelial Cell Density at All Post-baseline
Visits |
Up to month 18 |
Percent Change From Baseline in Endothelial Cell Density at All Post-baseline
Visits |
Up to month 18 |
| Change From Baseline in Guttae formation based on Modified Krachmer scale at All Post-baseline Visits |
Up to month 18 |
| Percent Change From Baseline in Guttae formation based on Modified Krachmer scale at All Post-baseline Visits |
Up to month 18 |
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Target Sample Size
|
Total Sample Size="80"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 2 |
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Date of First Enrollment (India)
|
15/02/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
19/05/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="4"
Days="0" |
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Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
none yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
The main objective of this study is to assess the efficacy of two concentrations of STN1010904 ophthalmic suspension (0.03%, and 0.1 %), twice daily dosing when compared to Placebo in subjects diagnosed with Fuchs Endothelial Corneal Dystrophy (FECD). |