PDR - Proliferative Diabetic RetinopathyEarly Phase 1NCT06412224
The Preliminary Safety and Efficacy of RRG001 After Vitrectomy in Subjects With Proliferative Diabetic Retinopathy (PDR)
A Early Phase 1 study testing RRG001 in people with PDR - Proliferative Diabetic Retinopathy, run by Li Xiaorong at 1 site in China.
Trial summary
This study aims to slow down disease progression, reduce postoperative complications and decrease retreatment frequency in subjects with proliferative diabetic retinopathy (PDR) by administering a single subretinal injection of RRG001 gene therapy after vitrectomy. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- PDR - Proliferative Diabetic Retinopathy
- What is being tested?
- RRG001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2023to 31 Dec 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to provide informed consent
- Age >= 20 years
- Diagnosis of diabetes mellitus (type 1 or type 2)
- The study eye diagnosed with PDR, in the opinion of the investigator, requires vitrectomy and postoperative anti-VEGF therapy, or that has undergone vitrectomy and still requires postoperative anti-VEGF therapy
- Based on the ETDRS chart, the best-corrected visual acuity (BCVA) of the study eye is ≥ hand motion and ≤ 63 letters
Who cannot join
- Active infection or inflammation in either eye
- Previous gene therapy in either eye
- Uncontrolled blood pressure（defined as systolic ≥160mmHg or diastolic ≥ 110mmHg by anti-hypertensive treatment)
- HbA1c >12% for diabetes patients at screening
- Previous condition not eligible for study drug
- History of major ocular surgery (except for PDR) or severe trauma
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- Currently enrolled in another clinical trial or planning to enroll during the study
- Pregnant or lactating women
- Other conditions that, in the opinion of the investigator, would preclude participation in the study
- Study Eye-Exclusion Criteria：
- Ocular disorders that, in the opinion of the investigator, would confound the interpretation of study results or affect the administration
- CNV or macular edema secondary to any causes other than diabetic retinopathy
- Ocular condition considered by the investigator to contraindicate subretinal injection
- Diagnosed primary or secondary glaucoma
- History of intraocular corticosteroid treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin medical university eye hospital
Tianjin
Xiaorong Li, Pro., 18622818042, xiaorli@163.com
About this study
Official title: An Exploratory ITT（Investigator Initiated Study) Study to Evaluate the Preliminary Safety and Efficacy of Single Subretinal Injection of RRG001 at the End of or After Vitrectomy in Subjects With PDR
This study aims to slow down disease progression, reduce postoperative complications and decrease retreatment frequency in subjects with proliferative diabetic retinopathy (PDR) by administering a single subretinal injection of RRG001 gene therapy after vitrectomy.
- Conditions
- PDR - Proliferative Diabetic Retinopathy
- Being tested
- RRG001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RRG001Drug
Administered by subretinal injection. Dosage form: injection.
| Study group | Role | What they receive |
|---|---|---|
| RRG001 | Experimental | Frequency of administration: one time injection. Receives: Drug: RRG001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the incidence of DLTs (dose limiting toxicity analysis) at most 6 subjcts
To evaluate the incidence of DLTs (dose limiting toxicity analysis) at most 6 subjcts
Measured: Within 28 days after RRG001 administration
To evaluate the incidence of AEs(Adverse Event) as assessed CTCAE 5.0 at most 6 subjcts
To evaluate the incidence of AEs as assessed CTCAE 5.0 at most 6 subjcts
Measured: Within 24 weeks after RRG001 administration
Secondary outcomes (7)
To evaluate the disease progression as assessed the vitreous hemorrhage of the study eye at most 6 subjects
To evaluate the disease progression as assessed the vitreous hemorrhage of the study eye at most 6 subjects
Measured: Within 24 weeks after RRG001 administration
To evaluate the disease progression as assessed the retinal detachment of the study eye at most 6 subjects
To evaluate the disease progression as assessed the retinal detachment of the study eye at most 6 subjects
Measured: Within 24 weeks after RRG001 administration
To evaluate the frequency for rescue therapy of the study eye at most 6 subjects
To evaluate the frequency for rescue therapy of the study eye at most 6 subjects
Measured: Within 24 weeks after RRG001 administration
To evaluate the change from baseline in BCVA(Best Corrected Visual Acuity) of the study eye as assessed by ETDRS chart at most 6 subjects
To evaluate the change from baseline in BCVA of the study eye as assessed by ETDRS chart at most 6 subjects
Measured: Within 24 weeks after RRG001 administration
To evaluate the anatomical changes of the study eye by OCT(optical coherence tomography) at most 6 subjects
To evaluate the anatomical changes of the study eye by OCT(optical coherence tomography) at most 6 subjects
Measured: Within 24 weeks after RRG001 administration
To evaluate the anatomical changes of the study eye by CFP(colour fundus photography）at most 6 subjects
To evaluate the anatomical changes of the study eye by CFP(colour fundus photography）at most 6 subjects
Measured: Within 24 weeks after RRG001 administration
To evaluate the anatomical changes of the study eye by OCTA（optical coherence tomography angiography) at most 6 subjects
To evaluate the anatomical changes of the study eye by OCTA（optical coherence tomography angiography) at most 6 subjects
Measured: Within 24 weeks after RRG001 administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start20 Dec 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PDR - Proliferative Diabetic RetinopathyStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li Xiaorong
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Refreshgene Technology Co., Ltd.
- Responsible party
- Sponsor-investigator, Li Xiaorong, Tianjin Medical University Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412224
- Sponsor's protocol ID
- RRG001-P01
- Status last verified
- May 2024
- First submitted
- 24 Apr 2024
- Last updated
- 14 May 2024
- 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 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory ITT（Investigator Initiated Study) Study to Evaluate the Preliminary Safety and Efficacy of Single Subretinal Injection of RRG001 at the End of or After Vitrectomy in Subjects With PDR
- ClinicalTrials.gov ID
- NCT06412224
- Acronym / sponsor ID
- RRG001-P01
- Conditions
- PDR - Proliferative Diabetic Retinopathy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Li XiaorongUniversity, hospital or other
- Collaborators
- Shanghai Refreshgene Technology Co., Ltd.
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 14 May 2024 (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 aims to slow down disease progression, reduce postoperative complications and decrease retreatment frequency in subjects with proliferative diabetic retinopathy (PDR) by administering a single subretinal injection of RRG001 gene therapy after vitrectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RRG001 | Experimental | Drug: RRG001Frequency of administration: one time injection. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able and willing to provide informed consent
- Age >= 20 years
- Diagnosis of diabetes mellitus (type 1 or type 2)
- The study eye diagnosed with PDR, in the opinion of the investigator, requires vitrectomy and postoperative anti-VEGF therapy, or that has undergone vitrectomy and still requires postoperative anti-VEGF therapy
- Based on the ETDRS chart, the best-corrected visual acuity (BCVA) of the study eye is ≥ hand motion and ≤ 63 letters
Key exclusion criteria (15 listed)
- Active infection or inflammation in either eye
- Previous gene therapy in either eye
- Uncontrolled blood pressure（defined as systolic ≥160mmHg or diastolic ≥ 110mmHg by anti-hypertensive treatment)
- HbA1c >12% for diabetes patients at screening
- Previous condition not eligible for study drug
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 |
|---|---|---|
| RRG001Administered by subretinal injection. Dosage form: injection. | Drug | RRG001 |
Primary outcome
To evaluate the incidence of DLTs (dose limiting toxicity analysis) at most 6 subjcts
Time frame: Within 28 days after RRG001 administration
To evaluate the incidence of DLTs (dose limiting toxicity analysis) at most 6 subjcts
To evaluate the incidence of AEs(Adverse Event) as assessed CTCAE 5.0 at most 6 subjcts
Time frame: Within 24 weeks after RRG001 administration
To evaluate the incidence of AEs as assessed CTCAE 5.0 at most 6 subjcts
7 secondary outcomes
To evaluate the disease progression as assessed the vitreous hemorrhage of the study eye at most 6 subjects
Time frame: Within 24 weeks after RRG001 administration
To evaluate the disease progression as assessed the retinal detachment of the study eye at most 6 subjects
Time frame: Within 24 weeks after RRG001 administration
To evaluate the frequency for rescue therapy of the study eye at most 6 subjects
Time frame: Within 24 weeks after RRG001 administration
To evaluate the change from baseline in BCVA(Best Corrected Visual Acuity) of the study eye as assessed by ETDRS chart at most 6 subjects
Time frame: Within 24 weeks after RRG001 administration
To evaluate the anatomical changes of the study eye by OCT(optical coherence tomography) at most 6 subjects
Time frame: Within 24 weeks after RRG001 administration
To evaluate the anatomical changes of the study eye by CFP(colour fundus photography）at most 6 subjects
Time frame: Within 24 weeks after RRG001 administration
To evaluate the anatomical changes of the study eye by OCTA（optical coherence tomography angiography) at most 6 subjects
Time frame: Within 24 weeks after RRG001 administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing RRG001 in people with PDR - Proliferative Diabetic Retinopathy, run by Li Xiaorong at 1 site in China.
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 5 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 14 May 2024. 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 China. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the incidence of DLTs (dose limiting toxicity analysis) at most 6 subjcts (time frame: Within 28 days after RRG001 administration). The study lists 2 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 14 May 2024.