Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001181594
Ethics application status
Approved
Date submitted
20/08/2024
Date registered
27/09/2024
Date last updated
27/09/2024
Date data sharing statement initially provided
27/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective study for use of a retinal sealant (PYK-2101) for participants undergoing vitrectomy for retinal detachment repair
Scientific title
A prospective surgical study evaluating the safety and tolerability of a novel, biodegradable retinal sealant (PYK-2101) following vitrectomy for retinal detachment repair
Secondary ID [1] 312687 0
Nil
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 334683 0
Vitrectomy 334684 0
Retinal Surgery 334686 0
Condition category
Condition code
Eye 331254 331254 0 0
Diseases / disorders of the eye
Surgery 331255 331255 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
PYK-2101 is a novel retinal sealant to be utilized in conjunction with vitrectomy in the repair of retinal detachment. PYK-2101 is an investigational product, a hydrogel, provided by Pykus Therapeutics to the selected investigators (ophthalmic surgeons) for use in the surgical suite and is a single use (single surgery) intervention.. During the vitrectomy (typically about a 30 minute procedure), 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. The application process is less than 5 minutes of the 30 minute procedure. This is a single use/dose product. a maximum volume administered will be 0.2mL. The surgeon and investigational team will follow the procedure as described in the protocol and Instructions For Use. They will be trained in use prior to site activation and prior to participant enrollment which is minimally one week in advance of treatment. This is a single one hour training provided by members of the Pykus Therapeutics team. The training is a combination of live in-in person, and video provided training. The site has had previous experience in the preparation and application of hydrogel, however this is a new formulation. The device is anticipated to biodegrade at approximately 6 weeks.. Compliance is assessed via objective imaging during the treatment (surgical video) and post-operative day one via Slit-lamp assessement with dilated funduscopy; wide-field color fundus photography, Macular SD-OCT. .
Intervention code [1] 329216 0
Treatment: Surgery
Intervention code [2] 329469 0
Treatment: Other
Comparator / control treatment
No control group or similar
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339028 0
Rate of Adverse events occuring for all participants. Anticipated adverse events specific to use of the device include; inflammation; elevated Intra Ocular Pressure (IOP); recurrent retinal detachment.
Timepoint [1] 339028 0
At each visit, participants will be assessed for changes from their baseline assessments (screening visit, day of procedure, post-procedure day 1, week 1, week 3, week 4.5, week 6 , and week 12.
Visual Acuity , Full Ophthamic exam, wide-field color fundus photography, and Macular SD-OCT will be performed at screening visit, post-procedure day 1, week 1, week 3, week 6 , and week 12. BCVA will be assessed at screening visit and week 12.
Primary outcome [2] 339029 0
Visual acuity changes from baseline
Timepoint [2] 339029 0
Visual acuity will be assessed at screening, post-procedure day 1, week 1, week 3, week 6 and week 12
Primary outcome [3] 339030 0
Lens changes from baseline:
Timepoint [3] 339030 0
Lens status will be assessed at screening, post-procedure day 1, week 1, week 3, week 4.5, week 6, and week 12.
Secondary outcome [1] 438310 0
Incidence of recurrent retinal detachment
Timepoint [1] 438310 0
The Wide-field color fundus photograph and Macular SD-OCT is assessed at screening, post-procedure day 1, week 1, week 3, week 6, and week 12
Secondary outcome [2] 438311 0
Changes to Quality of Life related to post surgical physical positioning requirements assessed utilizing the 5Q-5D-5L assessment questionnaire at at screening, post-procedure day 1, week 1, week 3, week 6, and week 12
Timepoint [2] 438311 0
The 5Q-5D-5L assessment questionnaire is implemented at screening, post-procedure day 1, week 1, week 3, week 6, and week 12 visits.
Secondary outcome [3] 439598 0
intra-ocular pressure (IOP) change from baseline. This is an additional primary outcome.
Timepoint [3] 439598 0
IOP will be assessed at screening, post-procedure day 1, week 1, week 3, week 4.5, week 6, and week 12.
Secondary outcome [4] 439599 0
Cataract progression (if phakic) or degree of IOL (Intraocular Lens) changes (if pseudophakic). This is an additional primary outcome.
Timepoint [4] 439599 0
IOP will be assessed at screening, post-procedure day 1, week 1, week 3, week 4.5, week 6, and week 12.

Eligibility
Key inclusion criteria
1. Age 18 or older of any gender
2. Undergoing vitrectomy for repair of primary rhegmatogenous retinal detachment with no more than 6 retinal breaks in total
a. Primary detachment refers to rhegmatogenous detachment that occurs in a previously uninvolved eye without any complicating factors (e.g., proliferative vitreoretinopathy or penetrating trauma)
3. Phakic or pseudophakic
4. Willing to participate in the study as evidenced by signing of an informed consent document
Minimum age
18 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 Hyaluronic Acid (HA); or Polyethylene Glycol (PEG)
3. Aphakic
4. Any prior history of uveitis, or other inflammatory or rheumatologic disease
5. A history of neovascularization of the iris (NVI) or the angle (NVA)
6. Known contraindication to using topical glaucoma drops or oral acetazolamide
7. 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
8. Participation in any clinical study of an investigational product within 30 days prior to enrollment, or any other planned eye surgery during the course of the study
Intraoperative Exiting Criteria
If any of the following are observed prior to attempted use of the investigational device, the subject will not receive the device and will be exited from the study:
1. Inability to flatten the retina
2. Presence of proliferative vitreoretinopathy (PVR), need to create a retinectomy, or retinal breaks larger than one clock hour
3. No more than 6 retinal breaks in total are permitted; breaks in any quadrant are permitted
4. Significant intraoperative retinal and/or choroidal bleeding
5. Any condition, intraoperative complication, or circumstance that in the opinion of the surgeon investigator, would compromise the safety of the subject, or the quality/interpretation 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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
The sample size of 10 completed subjects is commonly used in early-stage clinical development pilot studies of safety and tolerability and was not chosen to provide a specified amount of inferential statistical power.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/09/2024
Actual
Date of last participant enrolment
Anticipated
28/02/2025
Actual
Date of last data collection
Anticipated
28/05/2025
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 26903 0
Hobart Eye Surgeons - Hobart
Recruitment postcode(s) [1] 42961 0
7000 - Hobart

Funding & Sponsors
Funding source category [1] 317119 0
Commercial sector/Industry
Name [1] 317119 0
Pykus Australia Pty Ltd
Country [1] 317119 0
Australia
Funding source category [2] 317121 0
Commercial sector/Industry
Name [2] 317121 0
Pykus Therapeutics Inc
Country [2] 317121 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Pykus Therapeutics Inc.
Address
Country
United States Minor Outlying Islands
Secondary sponsor category [1] 319378 0
Commercial sector/Industry
Name [1] 319378 0
Pykus Australia Pty Ltd
Address [1] 319378 0
Country [1] 319378 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315873 0
Bellberry Human Research Ethics Committee L
Ethics committee address [1] 315873 0
Ethics committee country [1] 315873 0
Australia
Date submitted for ethics approval [1] 315873 0
17/07/2024
Approval date [1] 315873 0
19/08/2024
Ethics approval number [1] 315873 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136050 0
Dr Nitin Verma
Address 136050 0
Hobart Eye Surgeons 182 Argyle Street Hobart TAS Australia 7000
Country 136050 0
Australia
Phone 136050 0
+61 4 1787 3213
Fax 136050 0
Email 136050 0
[email protected]
Contact person for public queries
Name 136051 0
Tomasz P. Stryjewski
Address 136051 0
Pykus Therapeutics 1000 Massachusetts Ave, Suite 101, Cambridge, MA 02138
Country 136051 0
United States of America
Phone 136051 0
+01 617 394 8960
Fax 136051 0
Email 136051 0
[email protected]
Contact person for scientific queries
Name 136052 0
Tomasz P. Stryjewski
Address 136052 0
Pykus Therapeutics 1000 Massachusetts Ave, Suite 101, Cambridge, MA 02138
Country 136052 0
United States of America
Phone 136052 0
+01 617 394 8960
Fax 136052 0
Email 136052 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/feasibility 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.