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Tests treatment safety and results for Macular Telangiectasia Type 2 (MacTel)
Official title Phase 4 Study: Long-term Safety and Efficacy of NT-501 in MacTel Type 2, Including Sham Procedure Participants
ClinicalTrials.gov ID: NCT06971939
What this study is testing
What is NT-501/revakinagene taroretcel-lwey?
NT-501/revakinagene taroretcel-lwey is an investigational medicine, being studied as a potential treatment for macular telangiectasia type 2 (mactel).
Also referred to as ENCELTO.
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
- The purpose of this global, multicenter, open-label, Phase 4 clinical extension study is to evaluate the long-term safety and efficacy of revakinagene taroretcel-lwey (Encelto™; hereinafter referred to as NT-501), in participants with macular telangiectasia type 2 (MacTel) who previously received the intraocular implant in a Phase 1, Phase 2, or Phase 3 clinical study. In addition, this study will evaluate the safety and efficacy of NT501 in participants who previously underwent the sham procedure in a Phase 3 MacTel clinical study and elect to have NT-501 implanted intraocularly in this Phase 4 study.
- Phase 4: studies an already-approved treatment
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
- To be eligible to participate in this study, an individual participant must meet all the following criteria:
- Male or female adult participants who previously completed an NT-501 MacTel clinical study and:
- Arm 1: received NT-501 intraocular implant in either Phase 3 study (NTMT-03-A or NTMT-03-B)
- Arm 2: received NT-501 intraocular implant in the Phase 1 study (NTMT-01), Phase 2 study (NTMT-02), or in the substudy of the Phase 1 and Phase 2...
- Arm 3: underwent the sham procedure in either Phase 3 study (NTMT-03-A or NTMT-03-B)
You likely can't join if
- To participate in this study, the potential participant must not meet any of the following criteria. (Note that the ocular exclusion criteria are...
- Participant is medically unable to comply with clinical study procedures or visits.
- Participant has, in the opinion of the investigator, any physical or mental condition that would increase the risk of participation in the study or...
- Participant has significant corneal or media opacities in the study eye to be implanted.
- Participant has evidence of pathologic myopia in the study eye to be implanted.
- Participant has any of the following lens opacities in the study eye to be implanted: cortical opacity \> standard 3, posterior subcapsular opacity...
See the full eligibility criteria
- To be eligible to participate in this study, an individual participant must meet all the following criteria:
- Male or female adult participants who previously completed an NT-501 MacTel clinical study and:
- Arm 1: received NT-501 intraocular implant in either Phase 3 study (NTMT-03-A or NTMT-03-B)
- Arm 2: received NT-501 intraocular implant in the Phase 1 study (NTMT-01), Phase 2 study (NTMT-02), or in the substudy of the Phase 1 and Phase 2 extension study (NTMT-01/02E) Note: participants who received NT-501 in...
- Arm 3: underwent the sham procedure in either Phase 3 study (NTMT-03-A or NTMT-03-B)
- Participants must have steady fixation in the foveal or parafoveal area and sufficiently clear media for good quality retinal imaging.
- Participant or their legally authorized representative must be able to provide written informed consent to participate in the study, in accordance with the International Conference on Harmonisation (ICH) Good Clinical...
- Arm 3: female participants of childbearing potential must agree to use highly effective contraception. Highly effective forms of contraception (generally a first-year typical use pregnancy risk of 1% or less) include...
- To participate in this study, the potential participant must not meet any of the following criteria. (Note that the ocular exclusion criteria are relevant to the study eye(s), unless indicated for both eyes): Exclusion...
- Participant is medically unable to comply with clinical study procedures or visits.
- Participant has, in the opinion of the investigator, any physical or mental condition that would increase the risk of participation in the study or may interfere with the study procedures, evaluations, and outcome...
- Participant has significant corneal or media opacities in the study eye to be implanted.
- Participant has evidence of pathologic myopia in the study eye to be implanted.
- Participant has any of the following lens opacities in the study eye to be implanted: cortical opacity \> standard 3, posterior subcapsular opacity \> standard 2, or a nuclear opacity \> standard 3 as measured on the...
- Participant has undergone lens removal in the study eye to be implanted in the previous 3 months or YAG laser within 4 weeks of the screening/baseline visit.
- Participant has evidence of ocular disease in the study eye to be implanted other than MacTel that, in the judgment of the examining physician, may confound the diagnosis, procedures, or outcome of the study (eg...
- Received intravitreal steroid therapy in the study eye to be implanted within the last year.
- Received intravitreal anti-vascular endothelial growth factor therapy in the study eye to be implanted within the last 6 months.
- Evidence of active exudative intraretinal neovascularization or subretinal neovascularization in the study eye to be implanted, as evidenced by hemorrhage, hard exudate, subretinal fluid, or intraretinal fluid.
- Evidence of central serous chorioretinopathy in the study eye to be implanted.
- Participant underwent vitrectomy, penetrating keratoplasty, trabeculectomy, or trabeculoplasty in the study eye to be implanted.
- A history of ocular herpes virus in the study eye to be implanted.
- Participant is on chemotherapy.
- Participant is pregnant or breastfeeding.
- Participation in any other clinical study of an intervention (drug or device) within 6 months prior to the screening/baseline visit.
- A history of malignancy that would compromise survival during the clinical study.
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- Walnut Creek, California, United States
- Lakewood, Colorado, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Bethesda, Maryland, United States
- Frederick, Maryland, United States
- Boston, Massachusetts, United States
- Grand Rapids, Michigan, United States
- Minneapolis, Minnesota, United States
- Bloomfield, New Jersey, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Knoxville, Tennessee, United States
- Dallas, Texas, United States
+ 5 more site(s).
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 La Jolla, California, United States; Los Angeles, California, United States; Palo Alto, California, United States; Walnut Creek, California, United States; Lakewood, Colorado, United States; Miami, Florida, United States and 19 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.