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New treatment option for Diabetic Retinopathy
Official title Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema
ClinicalTrials.gov ID: NCT07592273
What this study is testing
What is Surabgene Lomparvovec?
Surabgene Lomparvovec is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for diabetic retinopathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Diabetic Retinopathy (DR) is a common eye condition caused by diabetes, where high blood sugar levels damage the blood vessels in the back part of the eye (called the retina). Over time, this damage can lead to vision problems and even blindness if not treated.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Ocular (Study Eye for Phase 2b and Phase 3 Portions; Both Eyes for Bilateral Portion)
- Moderately severe or severe nonproliferative diabetic retinopathy (NPDR) (early treatment diabetic retinopathy study-diabetic retinopathy severity...
- Best-corrected visual acuity (BCVA) in the study eye of \>= 69 Early treatment diabetic retinopathy study letters (approximate Snellen equivalent...
- Diabetic retinopathy (DR) secondary to diabetes mellitus Type 1 or 2 with a hemoglobin A1c (HbA1c)\< 12% within 60 days prior to Screening Visit 1.
You likely can't join if
- Ocular (Study Eye for Phase 2b and Phase 3 Portions; Both Eyes for Bilateral Portion)
- Presence of active center involved-diabetic macular edema (CI-DME) in the study eye as determined by spectral domain optical coherence tomography...
- Active ocular inflammation including scleral inflammation (including episcleritis) or ocular/ periocular infection present in either eye at Screening...
- Neovascularization from a cause other than DR, per investigator
- Evidence or documented history of panretinal photocoagulation (PRP) or retinal laser therapy
- History of intravitreal therapy, including anti-VEGF and long- or short-acting steroid therapy, within the prior 6 months and documentation of more...
See the full eligibility criteria
- Ocular (Study Eye for Phase 2b and Phase 3 Portions; Both Eyes for Bilateral Portion)
- Moderately severe or severe nonproliferative diabetic retinopathy (NPDR) (early treatment diabetic retinopathy study-diabetic retinopathy severity scale [DRSS] level 47 or 53) for which panretinal photocoagulation (PRP)...
- Best-corrected visual acuity (BCVA) in the study eye of \>= 69 Early treatment diabetic retinopathy study letters (approximate Snellen equivalent 20/40 or better) at Screening Visit 1. Systemic
- Diabetic retinopathy (DR) secondary to diabetes mellitus Type 1 or 2 with a hemoglobin A1c (HbA1c)\< 12% within 60 days prior to Screening Visit 1.
- Ocular (Study Eye for Phase 2b and Phase 3 Portions; Both Eyes for Bilateral Portion)
- Presence of active center involved-diabetic macular edema (CI-DME) in the study eye as determined by spectral domain optical coherence tomography (SD-OCT) evaluated by the central reading center (CRC), using the...
- Active ocular inflammation including scleral inflammation (including episcleritis) or ocular/ periocular infection present in either eye at Screening Visit 1 or Screening Visit 2
- Neovascularization from a cause other than DR, per investigator
- Evidence or documented history of panretinal photocoagulation (PRP) or retinal laser therapy
- History of intravitreal therapy, including anti-VEGF and long- or short-acting steroid therapy, within the prior 6 months and documentation of more than 10 prior anti-VEGF or short acting steroid intravitreal injections...
- Pregnant and breastfeeding individuals are excluded from this clinical study. Systemic
- Initiation of intensive insulin treatment (pump or multiple daily injections) within the past 6 months or plans to do so within 52 weeks after Day 1
- Initiation of any treatment containing a GLP-1 receptor agonist within the 3 months prior to Screening Visit 1 or plans to do so within 52 weeks after Day 1
- Pregnant and breastfeeding individuals are excluded from this clinical study
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Mountain View, California, United States
- Torrance, California, United States
- Durango, Colorado, United States
- Lakeland, Florida, United States
- Oak Forest, Illinois, United States
- Hagerstown, Maryland, United States
- Reno, Nevada, United States
- Beachwood, Ohio, United States
- Austin, Texas, United States
- Burleson, Texas, United States
- Dallas, Texas, United States
- Salem, Virginia, United States
- Arecibo, Puerto Rico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Mountain View, California, United States; Torrance, California, United States; Durango, Colorado, United States; Lakeland, Florida, United States; Oak Forest, Illinois, United States and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.