VX-01 for Diabetic Retinopathy

Recruiting in Palo Alto (17 mi)

+25 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Vantage Biosciences Ltd

Must not be taking: Anticoagulants, Steroids, GLP-1 modulators

Disqualifiers: Uncontrolled diabetes, Hypertension, Glaucoma, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of VX-01 as stand-alone treatment for Diabetic Retinopathy of Non-Proliferative Type (NPDR). The primary objective of the study is to evaluate the efficacy of daily oral doses of VX-01 versus placebo following 52 weeks of treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are currently using certain medications like coumarin anticoagulants (e.g., Warfarin) or strong inhibitors of the P-glycoprotein transporter. It's best to discuss your specific medications with the study team.

What data supports the effectiveness of the drug VX-01 for Diabetic Retinopathy?

Research shows that dexamethasone, a component of VX-01, is effective in treating diabetic macular edema, which is related to diabetic retinopathy. Studies have found that dexamethasone implants can improve vision and reduce swelling in the eye for patients with similar conditions.

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What safety data exists for VX-01 (dexamethasone intravitreal implant) in humans?

The dexamethasone intravitreal implant, also known as Ozurdex, has been studied for safety in conditions like macular edema and age-related macular degeneration. Some reported side effects include increased eye pressure and cataract formation, but it is generally considered safe for use in these eye conditions.

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Eligibility Criteria

This trial is for adults over 18 with a BMI of 18-40 kg/m2 who have Type 1 or Type 2 Diabetes Mellitus and moderate to severe Non-Proliferative Diabetic Retinopathy. Participants must not be pregnant, breastfeeding, and agree to use contraception if applicable. They should have clear eyes for imaging and no recent surgeries affecting reproductive status.

Inclusion Criteria

I have signed a consent form for this study.

I am over 18 years old.

I have been diagnosed with type 1 or type 2 diabetes.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily oral doses of VX-01 or placebo for 52 weeks

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Participant Groups

The study tests the effectiveness and safety of VX-01, an oral medication taken daily for one year against a placebo in treating Diabetic Retinopathy. It will also look at how the body processes the drug (pharmacokinetics) and its effects on the disease (pharmacodynamics).

Group I: VX-01 Experimental Treatment 1 Intervention

Cohort 1 will include 50 subjects who will be randomized to take investigational drug VX-01 (film-coated tablets) at dose of 150 mg, administered BID.

Group II: Placebo Placebo Group 1 Intervention

Cohort 2 will include 50 subjects who will be randomized to receive the placebo drug (film-coated tablets), that will be administered BID.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Retina-Vitreous Associates Medical Group Beverly Hills, CA

Stanford Byers Eye Institute Palo Alto, CA

California Retina Consultants- Santa Barbara Santa Barbara, CA

Florida Retina Institute - Jacksonville Southside Jacksonville, FL

More Trial Locations

Who Is Running the Clinical Trial?

Vantage Biosciences Ltd Lead Sponsor

Vantage Biosciences Australia Pty Ltd Industry Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

Dexamethasone intravitreal implant as adjunct therapy for patients with wet age-related macular degeneration with incomplete response to ranibizumab. [2022] To evaluate the visual and anatomical outcomes of dexamethasone intravitreal implant (DXI; 700 μg, Ozurdex; Allergan, Irvine, California, USA) as adjunctive therapy for patients with refractory wet age-related macular degeneration (AMD).

2. United States pubmed.ncbi.nlm.nih.gov

Intravitreal Dexamethasone in Patients with Wet Age-Related Macular Degeneration Resistant to Anti-VEGF: A Prospective Pilot Study. [2022] To evaluate the efficacy and safety of a single intravitreal dexamethasone implant (DXI) combined with intravitreal antivascular endothelial growth factor (anti-VEGF) therapy, in patients with neovascular age-related macular degeneration (wet-AMD) resistant to conventional treatment.

3. England pubmed.ncbi.nlm.nih.gov

Dexamethasone for unresponsive diabetic macular oedema: optical coherence tomography biomarkers. [2019] To analyse the effects of intravitreal dexamethasone implant (DEX) in patients with diabetic macular oedema (DME) unresponsive to ranibizumab treatment, in relation to the inflammatory optical coherence tomography (OCT) retinal features, subfoveal neuroretinal detachment (SND) and hyperreflective retinal spots (HRS).

4. England pubmed.ncbi.nlm.nih.gov

Intravitreal Dexamethasone Implant for the Treatment of Macular Edema in Chronic Non-infectious Uveitis. [2018] To report observations on the single and repeat use of the dexamethasone (DEX) intravitreal implant (Ozurdex; Allergan, Inc, Irvine, CA) for the treatment of macular edema in patients with non-infectious posterior segment uveitis.

5. United States pubmed.ncbi.nlm.nih.gov

Efficacy of dexamethasone intravitreal implant for the treatment of diabetic macular edema. [2018] To assess the efficacy of a single dexamethasone intravitreal implant (Dex-I) injection for the treatment of diabetic macular edema (DME).

6. United States pubmed.ncbi.nlm.nih.gov

OBSERVED COMPLICATIONS FROM DEXAMETHASONE INTRAVITREAL IMPLANT FOR THE TREATMENT OF MACULAR EDEMA IN RETINAL VEIN OCCLUSION OVER 3 TREATMENT ROUNDS. [2015] To report adverse events after treatment of macular edema secondary to retinal vein occlusion with intravitreal dexamethasone implant (IDI) in a UK center across three treatment rounds.

7. England pubmed.ncbi.nlm.nih.gov

Ozurdex in age-related macular degeneration as adjunct to ranibizumab (The OARA Study). [2022] To evaluate the utility of dexamethasone intravitreal implant (DXI; Ozurdex; Allergan, Irvine, Calif.) in combination with ranibizumab (Lucentis; Novartis Pharma AG, Basel, Switzerland) versus ranibizumab monotherapy on visual acuity (VA) and anatomical outcomes in a neovascular age-related macular degeneration (nAMD) cohort.

8. China pubmed.ncbi.nlm.nih.gov

Anatomical and functional changes after dexamethasone implant and ranibizumab in diabetic macular edema: a retrospective cohort study. [2020] To investigate the efficacy and safety of ranibizumab (RZB group) and dexamethasone implant (DEX group) intravitreal treatments in patients with treatment-naïve center involved diabetic macular edema (DME) by means of functional and morphological assessments.

9. United States pubmed.ncbi.nlm.nih.gov

Evaluation of retinal inflammatory biomarkers after intravitreal steroid implant and Ranibizumab injection in diabetic macular edema. [2022] To compare the efficacy of intravitreal (IV) ranibizumab (IVR) injection with IV dexamethasone implant (IVDEX) in treatment naive diabetic macular edema (DME) patients with inflammatory component.