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New treatment option for Retinitis Pigmentosa
Official title An Open-label, Dose-ascending Study of IGT001 for Retinitis Pigmentosa
ClinicalTrials.gov ID: NCT06936787
What this study is testing
What is IGT001?
IGT001 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for retinitis pigmentosa.
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
- This is an investigator-initiated, prospective, single-center, open-label, single ascending dose clinical study. The study aims to evaluate the safety, tolerability, and potential efficacy of intravitreal injection of IGT001 in patients with retinitis pigmentosa across different dose groups.
- Phase 1: an early, usually small safety study
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
- Adults aged ≥ 18 years at the time of signing the informed consent form, regardless of gender
- Clinical diagnosis of retinitis pigmentosa based on medical history and specialized examinations
- Willing to undergo genetic mutation testing, with results confirming known genetic mutations associated with hereditary retinal degeneration and...
- Willing to provide blood samples for HLA typing
- Blood cell counts (hematocrit, hemoglobin, white blood cells, platelets) within the normal range, or outside the normal range but deemed clinically...
You likely can't join if
- As determined by the investigator, the study eye has concurrent conditions in addition to retinitis pigmentosa that:
- Affect central vision, or
- Increase the safety risk for the participant, or
- Impact how well it works or safety assessments or data collection, or
- Require surgical or medical intervention due to ocular diseases or history, such as retinal detachment or a history of retinal detachment, wet...
- The study eye cannot rule out the differential diagnosis of pseudoretinitis pigmentosa or cancer-associated retinopathies.
See the full eligibility criteria
- Adults aged ≥ 18 years at the time of signing the informed consent form, regardless of gender
- Clinical diagnosis of retinitis pigmentosa based on medical history and specialized examinations
- Willing to undergo genetic mutation testing, with results confirming known genetic mutations associated with hereditary retinal degeneration and related diseases
- Willing to provide blood samples for HLA typing
- Blood cell counts (hematocrit, hemoglobin, white blood cells, platelets) within the normal range, or outside the normal range but deemed clinically insignificant by the investigator
- Negative screening results for infectious diseases (hepatitis B, hepatitis C, and HIV), with no history of drug abuse (confirmed by negative urine test)
- Female participants of childbearing potential (defined as those who have not undergone surgical sterilization or have not been postmenopausal for at least one year) must undergo a urine pregnancy test at the time of...
- As determined by the investigator, the study eye has concurrent conditions in addition to retinitis pigmentosa that:
- Affect central vision, or
- Increase the safety risk for the participant, or
- Impact how well it works or safety assessments or data collection, or
- Require surgical or medical intervention due to ocular diseases or history, such as retinal detachment or a history of retinal detachment, wet age-related macular degeneration, diabetic macular edema, retinal vein...
- The study eye cannot rule out the differential diagnosis of pseudoretinitis pigmentosa or cancer-associated retinopathies.
- History of malignant tumors (except for patients in remission for more than five years and those with basal cell carcinoma of the skin), end-stage major organ diseases (including heart failure, severe arrhythmias...
- History of glaucoma in either eye or a glaucoma diagnosis at screening
- History of ocular hypertension in either eye or a diagnosis of ocular hypertension at screening
- Intraocular pressure (IOP) \> 21 mmHg in either eye or current use of any intraocular pressure-lowering medications
- History of allergy, intolerance, or adverse reactions to any procedures involved in the study, including but not limited to a history of allergy/adverse reactions to contrast agents, needle phobia, or hemophobia
- History of ocular surface damage or drug-induced toxicity from medications such as deferoxamine, chloroquine/hydroxychloroquine (Plaquenil), tamoxifen, phenothiazines, or ethambutol
- History of allergy or adverse reactions to products containing dimethyl sulfoxide (DMSO)
- History of allergy to gentamicin
- Inability or unwillingness to comply with any study-related procedures, including genetic testing, blood sample collection, clinical examinations, or procedures requiring pupil dilation, topical anesthesia, or contrast...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Shanghai, China. 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.