Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000986875
Ethics application status
Approved
Date submitted
29/01/2021
Date registered
27/07/2021
Date last updated
27/01/2023
Date data sharing statement initially provided
27/07/2021
Date results information initially provided
27/01/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot safety study of an artificial vitreous (gel inside eye) as part of retinal detachment surgery for subjects requiring retinal repair.
Scientific title
A pilot study of a novel, biodegradable, polymeric vitreous substitute for post-operative retinal tamponade
Secondary ID [1] 303300 0
PYK-1105-RD001
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
retinal detachment 320517 0
vitrectomy 320518 0
Condition category
Condition code
Eye 318379 318379 0 0
Diseases / disorders of the eye
Surgery 318380 318380 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
PYK-1105 is a novel retinal tamponade and vitreous substitute to be utilized in conjunction with vitrectomy in the repair of retinal detachment. PYK-1105 is an investigational product, a hydrogel, provided by Pykus Therapeutics to the selected investigators (ophthalmic surgeons) for use in the surgical suite. During the vitrectomy, after all retinal breaks have been treated, the investigational product is prepared and is then administered via a cannula similar to what is already used routinely in retina surgery. The surgeon will apply a focused, micro delivery of gel to the site of retinal breaks so that all of the retinal breaks are completely covered which allows for a minimal amount of product. This is a single use/dose product. Approximately 0.02-0.15 mL will be applied in total. The product is expected to naturally degrade within 2-4 weeks. Compliance will be confirmed through review of the surgical record and post operative imaging.
Intervention code [1] 319605 0
Treatment: Surgery
Intervention code [2] 320061 0
Treatment: Other
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326353 0
The primary objective of this study is to evaluate the safety and tolerability of PYK-1105 within the first 24 weeks post vitrectomy. Evaluated measures include:
--Visual acuity at post-operative day 1, week 1, week 2, week 3, week 4, week 12 and week 24. Visual acuity will be assessed and will be recorded using existing prescription, if any, and using Best Corrected Visual Acuity with ETDRS charts.
Timepoint [1] 326353 0
Post-Operative Day 1, week 1, week 2, week 3, week 4, week 12, and 24 weeks
Primary outcome [2] 326913 0
--Adverse events occurring from the point of administration of the PYK-1105 through the subject’s final study assessment. Assessment of adverse events will identified through review of the medical record, and ophthalmic assessments including Visual Acuity, measurement of intraocular pressure, slit lamp exam, dilated fundoscopy and clinical labs as defined in the protocol
Grading is as follows:
Mild (Grade 1)-awareness of sign or symptom, but easily tolerated
Moderate (Grade II)-discomfort enough to cause interference with usual activity
Severe (Grade III)-incapacitating with inability to work or perform usual activity
Very Sever (Grade IV)-Vision or life-threatening; urgent intervention indicated
Death (Grade V)-death of subject
Timepoint [2] 326913 0
Post-Operative Day 1, week 1, week 2, week 3, week 4, week 12, and 24 weeks
Note: clinical laboratory samples will be tested pre-procedure; post-operative week 4; and terminal visit (post operative week 24).
Primary outcome [3] 326914 0
--Retinal attachment assessed by dilated fundosopy and SD-OCT
Timepoint [3] 326914 0
Post-Operative Day 1, week 1, week 2, week 3, week 4, week 12, and 24 weeks
Secondary outcome [1] 391134 0
Degree of cataract progression (if phakic) which will be assessed by full ophthalmic exam (inclusive of slit lamp examination)
Timepoint [1] 391134 0
Screening, Post-Operative Day 1, week 1, week 2, week 3, week 4, week 12, and 24 weeks
Secondary outcome [2] 397406 0
Degree of IOL (intraocular lens) changes (if pseudophakic) will be assessed for the 24 weeks of the subjects participation through clinical slit lamp evaluation.
Timepoint [2] 397406 0
Screening, Post-Operative Day 1, week 1, week 2, week 3, week 4, week 12, and 24 weeks

Eligibility
Key inclusion criteria
1. Age 21 or older of any gender
2. No plan for simultaneous phacoemulsification (e.g. phaco-vit) or lensectomy
3. At least LogMAR BCVA 1.3 (Snellen equivalent 20/400) or worse in the affected eye
4. At least LogMAR BCVA 0.3 (Snellen equivalent 20/40) or better in the unaffected eye and no active significant ocular disease (such as proliferative diabetic retinopathy or advanced glaucoma) that may result in future loss of vision
5. Phakic, pseudophakic, or aphakic
6. Undergoing vitrectomy for repair of rhegmatogenous or tractional-rhegmatogenous retinal detachment
7. Evidence of poor visual prognosis in the operative eye
i. Poor visual prognosis may include but is not limited to: history of poor baseline vision (20/100 vision or worse), history of a macula-off detachment of more than 6 weeks duration, history of multiple recurrent retinal detachments, history of macular ischemia, presence of combined tractional-rhegmatogenous detachment, history of retinal detachment associated with endophthalmitis/infectious retinitis that is now inactive, history of retinal detachment associated with open globe injury, or other concomitant ocular condition, which in the opinion of the surgeon investigator, would preclude a visual recovery to an ambulatory level (>20/100) if conventional tamponade methods were used.
8. Willing to participate in the study as evidenced by signing of an informed consent document.
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnancy or breastfeeding
2. Known allergy to PVA or PEG
3. Presence of significant pre-existing corneal disease (e.g. history of corneal dystrophy, history of corneal transplant, history of non-healing epithelial defect)
4. A history of uveitis, or a history of any other inflammatory or rheumatologic disease (not including inactive endophthalmitis or retinitis)
5. A history of glaucoma, glaucoma suspect, ocular hypertension (baseline IOP greater than 20mm Hg), ongoing use of IOP lowering agents, or prior use of IOP lowering agents
6. Narrow anatomical angles or presence of neovascularization of the iris (NVI) or the angle (NVA)
7. Known contraindication to using topical glaucoma drops or oral acetazolamide
8. Presence of an optic pit
9. More than one clock hour of Grade C proliferative vitreoretinopathy (PVR)
10. Any condition or circumstance that, in the opinion of the surgeon investigator, would compromise the safety of the subject or the quality of study data
11. Participation in any clinical study of an investigational product within 30 days prior to enrollment
Exclusion Criteria - Intraoperative
12. Inability to completely flatten the retina
13. Significant retinal bleeding
14. Any condition, intraoperative complication, or circumstance that in the opinion of the surgeon investigator, would compromise the safety of the subject or the quality of study data

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This is a multicenter, single cohort, non-masked study, 10 (ten) subjects with rhegmatogenous or tractional- rhegmatogenous retinal detachment undergoing pars plana vitrectomy will be enrolled and will receive the retinal tamponade device PYK-1105.
Given the pilot nature of the study, subjects will be enrolled who have limited visual potential in the affected eye or have medical comorbidities that would prevent proper positioning post-operatively if using conventional methods of retinal tamponade.
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
The sample size of 10 completed subjects is commonly used in pilot studies of safety and tolerability and was not chosen to provide a specified amount of inferential statistical power. With 10 subjects receiving PYK-1105, the study will have about 90% power to detect an AE with an actual frequency of about 20%.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Safety concerns
Other reasons/comments
Other reasons
Investigational material expired during the time period in which we had paused to evaluate safety concerns.
Date of first participant enrolment
Anticipated
Actual
5/02/2021
Date of last participant enrolment
Anticipated
31/03/2022
Actual
12/04/2022
Date of last data collection
Anticipated
30/09/2022
Actual
27/09/2022
Sample size
Target
10
Accrual to date
Final
7
Recruitment in Australia
Recruitment state(s)
NSW,TAS
Recruitment hospital [1] 18520 0
Sydney Hospital and Sydney Eye Hospital - Sydney
Recruitment hospital [2] 18521 0
Sydney Retina Clinic & Day Surgery - Sydney
Recruitment hospital [3] 20087 0
Hobart Eye Surgeons - Hobart
Recruitment postcode(s) [1] 32860 0
2000 - Sydney
Recruitment postcode(s) [2] 34795 0
7000 - Hobart

Funding & Sponsors
Funding source category [1] 307715 0
Commercial sector/Industry
Name [1] 307715 0
Pykus Australia Pty Ltd.
Country [1] 307715 0
Australia
Funding source category [2] 307718 0
Commercial sector/Industry
Name [2] 307718 0
Pykus Therapeutics Inc.
Country [2] 307718 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Pykus Therapeutics Inc.
Address
1 Mifflin Place, Suite 320 | Cambridge MA 02138
Country
United States of America
Secondary sponsor category [1] 308416 0
Commercial sector/Industry
Name [1] 308416 0
Pykus Australia Pty Ltd.
Address [1] 308416 0
Floor 17, HWT Tower
40 City Road Southbank
Victoria 3006
Australia
Country [1] 308416 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307746 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 307746 0
123 Glen Osmond Road
Eastwood, South Australia 5063
Ethics committee country [1] 307746 0
Australia
Date submitted for ethics approval [1] 307746 0
22/10/2020
Approval date [1] 307746 0
11/11/2020
Ethics approval number [1] 307746 0
2020-10-1050

Summary
Brief summary
The purpose of this research project is to provide a new alternative to currently approved methods of sealing retinal breaks (retinal tamponade) and substitute for the liquid portion (vitreous) of your eye. Tamponade is a required action for the standard surgery required for retinal detachment repair. The name of the investigational product in this study is PYK-1105. PYK-1105 will be injected during surgery as a vitreous substitute and tamponade. Use of the investigational product will prevent subjects from having to remain in a face down position for a number of days, will not limit their ability for air travel for a period of time, nor require an additional surgery to remove the tamponade and may have improved visual clarity as compared to other methods.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes
N/A

Contacts
Principal investigator
Name 108354 0
Dr Thomas Pham
Address 108354 0
Sydney Retina Clinic and Day Surgery
Level 13, Park House, 187 Macquarie Street
Sydney. NSW. 2000
Country 108354 0
Australia
Phone 108354 0
+61 2 9221 3755
Fax 108354 0
Email 108354 0
[email protected]
Contact person for public queries
Name 108355 0
Mr Thomas Hong
Address 108355 0
Sydney Retina Clinic and Day Surgery
Level 13, Park House, 187 Macquarie Street
Sydney. NSW. 2000
Country 108355 0
Australia
Phone 108355 0
+61 2 9221 3755
Fax 108355 0
Email 108355 0
[email protected]
Contact person for scientific queries
Name 108356 0
Dr Tomasz P. Stryjewski
Address 108356 0
Pykus Therapeutics
1 Mifflin Place, Suite 320 | Cambridge, MA 02138
Country 108356 0
United States of America
Phone 108356 0
+01 617 394 8960
Fax 108356 0
Email 108356 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a pilot study which will only generate safety data in a minimal number of subjects.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.