The Preliminary Safety and Efficacy of RRG001 After Vitrectomy in Subjects With Proliferative Diabetic Retinopathy (PDR)

PDR - Proliferative Diabetic Retinopathy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06412224
• Other study ID #: RRG001-P01
• Status: Recruiting
• Phase: Early Phase 1
• Start date: December 20, 2023
• Est. completion date: December 31, 2028

Study information

• Verified date: May 2024
• Source: Tianjin Medical University Eye Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• PDR - Proliferative Diabetic Retinopathy
• Retinal Diseases

Intervention

Drug:
• RRG001
Administered by subretinal injection. Dosage form: injection.

Locations

Country	Name	City	State
China	Tianjin medical university eye hospital	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Li Xiaorong	Shanghai Refreshgene Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Within 28 days after RRG001 administration
Primary	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	Within 24 weeks after RRG001 administration
Secondary	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	Within 24 weeks after RRG001 administration
Secondary	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	Within 24 weeks after RRG001 administration
Secondary	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	Within 24 weeks after RRG001 administration
Secondary	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	Within 24 weeks after RRG001 administration
Secondary	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	Within 24 weeks after RRG001 administration
Secondary	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	Within 24 weeks after RRG001 administration
Secondary	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	Within 24 weeks after RRG001 administration