Retinitis PigmentosaNCT04008771
Intravitreal Injection of SeeQ CdSe 655 Alt Nanoparticles for Patients With Degenerative Retinal Diseases
A study testing SeeQ CdSe 655 ALT in people with Retinitis Pigmentosa, run by 2C Tech Corp at 1 site in Mexico.
Trial summary
This study was a prospective, open label feasibility study conducted at a single clinical site (APEC, Mexico City) to evaluate the safety and preliminary effectiveness of the SeeQ device, with each patient's serving as his/her own contralateral control. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Retinitis Pigmentosa
- What is being tested?
- SeeQ CdSe 655 ALT
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteMexico
- Study dates
- 6 Jan 2014to 19 Dec 2014
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects, 21 years of age or older.
- Subjects with a history of degenerative retinal diseases such as RP.
- Subjects with a documented history of disease progression.
- Willing and able to return for all study visits.
- Willing and able to provide written informed consent for the Clinical Study.
- Subjects with a BCVA greater or equal to 20/16000 must have consistent fixation demonstrated by indirect ophthalmoscopy with a small circle of light and by consistent location of remaining central visual field detected by VFA.
- Study Arm A: The best corrected visual acuity must be between 20/16000 and HM as tested by ETDRS chart and ERG B wave amplitude.
- Study Arm B: The best-corrected visual acuity must be between 20/60 and 20/16000 and visual field of central 15 degrees (III static 30-2 protocol, 31.5 ASB background) greater than 10 dB loss, as determined by a Humphrey Instruments, Inc. Visual Field Analyzer (VFA).
Who cannot join
- Subjects with significant lens or corneal pathology (either history of or current) in the study eye other than retinal diseases.
- Subjects with high myopia in the study eye (axial length greater than or equal to 26.0 millimeters by ultrasound or spherical equivalent at the spectacle plane greater than -8.0 diopters.)
- Subjects whose retinal disease status has been stable for more than 90 days.
- Subjects with history of iritis or uveitis in either eye.
- Subjects who have monocular vision.
- Subjects with a history of retinal detachment or tear in either eye.
Show all 19Show fewer
- Subjets with unstable IOP (i.e. > 30 mmHg in the past six months) or IOP of > 24 mm Hg at enrollment while under medical control. Subjects may be on topical medications to control their IOP.
- Subjects with an aphakic study ete or if pseudophakic, cataract extraction surgery more than 6 months prior to study enrollment.
- Subjects with a history of ocular trauma of any type in the study eye.
- Subjects with media opacities or abnormalities that would preclude observation of the retina in the study eye, per the investigator's judgement.
- Subjects that have undergone any previous vitrectomy (either anterior or pars plana vitrectomy in the study eye).
- Subjects with a history of cataract surgery complication in the study eye.
- Subjects that have undergone previous photocoagulation of the retina in the study eye.
- Subjects anticipated requiring cataract extraction in the study eye within the next six (6) months.
- Subjects with congenital eye malformations.
- Recurrent uveitis or history of uveitis in either eye.
- Macular edema or history of macular edema in the study eye where central macular thickness is greater than 275 microns by OCT at baseline.
- Ongoing ocular infection or inflammation in the study eye.
- Pregnant or nursing females.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Asociacion Para Evitar La Ceguera En Mexico, I.A.P. (APEC)
Mexico City
About this study
Official title: A Phase 1 Safety And Effectiveness Study of Intravitreal Injection of SeeQ CdSe 655 Alt Nanoparticles for Patients With Degenerative Retinal Diseases
This study was a prospective, open label feasibility study conducted at a single clinical site (APEC, Mexico City) to evaluate the safety and preliminary effectiveness of the SeeQ device, with each patient's serving as his/her own contralateral control.
- Conditions
- Retinitis Pigmentosa
- Being tested
- SeeQ CdSe 655 ALT
- Medical subject headings
- Retinitis Pigmentosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeeQ CdSe 655 ALTDevice
SeeQ CdSe 655 Alt is a sterile colloidal solution of coated CdSe nanoparticles in a borate buffer suitable for intraocular injection.
| Study group | Role | What they receive |
|---|---|---|
| Severe Disease | Experimental | Subjects with baseline BCVA between 20/16000 and hand motion (HM). Subjects received 2.0 μM concentration intravitreal injections on each Day 0 and Day 21. Receives: Device: SeeQ CdSe 655 ALT |
| Moderate to Severe Disease | Experimental | Subjects with baseline BCVA from 20/60 to 20/16000. The first five (5) to receive 2.0 μM concentration intravitreal at each Day 0 and Day 21, the subsequent five (5) to receive 0.2 μM intravitreal injection at each Day 0 and Day 21, additional subjects (up to ten [10]) to receive one of the dosing options (either 2.0 μM or 0.2 μM) at each Day 0 and Day 21, at the discretion of the Investigator and Sponsor. Receives: Device: SeeQ CdSe 655 ALT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Best Corrected Visual Acuity "BCVA"
Measured: Measured at Baseline through Day 42
Change in Contrast Sensitivity
Contrast sensitivity was measured utilizing a sin wave (Vistech) contrast sensitivity chart under photopic conditions
Measured: Measured at Baseline through Day 42
Change in ERG Amplitude
ERG amplitude was measured using Poland Consult ERG equipment
Measured: Measured at Baseline through Day 42
Change in Visual Fields
Visual Field improvement is assessed using a Humphrey/Zeiss Visual Field Analyzer
Measured: Measured at Baseline through Day 42
Change in Functional Vision
Functional Vision is tested using Object identification and White line orientation testing
Measured: Measured at Baseline through Day 42
Secondary outcomes (1)
Duration of Effect
Measured: Measured at Baseline through Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start6 Jan 2014
- Primary completion19 Dec 2014
- Study completion19 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinitis PigmentosaStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This study was a prospective, open label feasibility study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- 2C Tech Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008771
- Sponsor's protocol ID
- SeeQ 101.A
- Status last verified
- Jul 2019
- First submitted
- 25 Jun 2019
- Last updated
- 5 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Safety And Effectiveness Study of Intravitreal Injection of SeeQ CdSe 655 Alt Nanoparticles for Patients With Degenerative Retinal Diseases
- ClinicalTrials.gov ID
- NCT04008771
- Acronym / sponsor ID
- SeeQ 101.A
- Conditions
- Retinitis Pigmentosa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- 2C Tech CorpIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2014 (actual)
- Primary completion
- 19 Dec 2014 (actual)
- Study completion
- 19 Dec 2014 (actual)
- First posted
- 5 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.
This study was a prospective, open label feasibility study conducted at a single clinical site (APEC, Mexico City) to evaluate the safety and preliminary effectiveness of the SeeQ device, with each patient's serving as his/her own contralateral control.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study was a prospective, open label feasibility study
| Arm | Type | Receives |
|---|---|---|
| Severe Disease | Experimental | Device: SeeQ CdSe 655 ALTSubjects with baseline BCVA between 20/16000 and hand motion (HM). Subjects received 2.0 μM concentration intravitreal injections on each Day 0 and Day 21. |
| Moderate to Severe Disease | Experimental | Device: SeeQ CdSe 655 ALTSubjects with baseline BCVA from 20/60 to 20/16000. The first five (5) to receive 2.0 μM concentration intravitreal at each Day 0 and Day 21, the subsequent five (5) to receive 0.2 μM intravitreal injection at each Day 0 and Day 21, additional subjects (up to ten [10]) to receive one of the dosing options (either 2.0 μM or 0.2 μM) at each Day 0 and Day 21, at the discretion of the Investigator and Sponsor. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subjects, 21 years of age or older.
- Subjects with a history of degenerative retinal diseases such as RP.
- Subjects with a documented history of disease progression.
- Willing and able to return for all study visits.
- Willing and able to provide written informed consent for the Clinical Study.
Key exclusion criteria (19 listed)
- Subjects with significant lens or corneal pathology (either history of or current) in the study eye other than retinal diseases.
- Subjects with high myopia in the study eye (axial length greater than or equal to 26.0 millimeters by ultrasound or spherical equivalent at the spectacle plane greater than -8.0 diopters.)
- Subjects whose retinal disease status has been stable for more than 90 days.
- Subjects with history of iritis or uveitis in either eye.
- Subjects who have monocular vision.
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 |
|---|---|---|
| SeeQ CdSe 655 ALTSeeQ CdSe 655 Alt is a sterile colloidal solution of coated CdSe nanoparticles in a borate buffer suitable for intraocular injection. | Device | Moderate to Severe Disease, Severe Disease |
Primary outcome
Change in Best Corrected Visual Acuity "BCVA"
Time frame: Measured at Baseline through Day 42
Change in Contrast Sensitivity
Time frame: Measured at Baseline through Day 42
Contrast sensitivity was measured utilizing a sin wave (Vistech) contrast sensitivity chart under photopic conditions
Change in ERG Amplitude
Time frame: Measured at Baseline through Day 42
ERG amplitude was measured using Poland Consult ERG equipment
Change in Visual Fields
Time frame: Measured at Baseline through Day 42
Visual Field improvement is assessed using a Humphrey/Zeiss Visual Field Analyzer
Change in Functional Vision
Time frame: Measured at Baseline through Day 42
Functional Vision is tested using Object identification and White line orientation testing
1 secondary outcome
Duration of Effect
Time frame: Measured at Baseline through Day 42
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SeeQ CdSe 655 ALT in people with Retinitis Pigmentosa, run by 2C Tech Corp at 1 site in Mexico.
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 8 inclusion and 19 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: finished, as of the sponsor's last update on 5 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 Mexico. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Best Corrected Visual Acuity "BCVA" (time frame: Measured at Baseline through Day 42). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jul 2019.