Wet Age Related Macular Degeneration study: NT-101 ophthalmic solution
Official title A Phase 2 Study of NT-101 Topical in Patients With Wet AMD
ClinicalTrials.gov ID: NCT07811726
What this study is testing
What is NT-101 ophthalmic solution?
This is an investigational eye drop being studied as a potential treatment for wet age-related macular degeneration.
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 study aims to find out if the new eye drop is effective and safe for treating wet age-related macular degeneration.
- Who it's for
- The study is looking for people who have wet age-related macular degeneration.
- What's involved
- Participants will put a drop in their eye twice a day for 12 weeks. They will also have regular check-ups and tests to monitor their health.
- Time commitment
- The study lasts 12 weeks and requires regular visits to the clinic.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- Subject who is male or female ≥ 50 years of age at Screening.
- CNV lesions affect the fovea, as evidenced by fluorescein angiography in study eye.
- Intraretinal and/or subretinal fluid affecting the central subfield visible on OCT.
- BCVA between 35 and 78 letters, inclusive, in the study eye at Screening using ETDRS testing, with BCVA decrement primarily attributable to wet AMD.
- Lucentis (ranibizumab): 30-day washout
You likely can't join if
- Uncontrolled hypertension (systolic \> 180 mmHg or diastolic \> 100 mmHg) despite optimal medical regimen
- Uncontrolled diabetes (HbA1c \> 12.0%)
- Total bilirubin \> 1.5 × Upper Limit of Normal (ULN)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2.5 × ULN
- Prothrombin time (PT) \> 1.5 × ULN
- Hemoglobin (Hb) \< 10 g/dL (male); Hb \< 9 g/dL (female)
See the full eligibility criteria
Who can join
- Subject who is male or female ≥ 50 years of age at Screening.
- CNV lesions affect the fovea, as evidenced by fluorescein angiography in study eye.
- Intraretinal and/or subretinal fluid affecting the central subfield visible on OCT. If fluid is not visible due to previous treatment, earlier documented OCT images showing fluid for diagnosing wet AMD can be reviewed...
- BCVA between 35 and 78 letters, inclusive, in the study eye at Screening using ETDRS testing, with BCVA decrement primarily attributable to wet AMD.
- Lucentis (ranibizumab): 30-day washout
- Avastin (bevacizumab): 30-day washout
- Eylea (aflibercept): 60-day washout
- Eylea (aflibercept) high dose 8mg: 70-day washout
- Vabysmo (faricimab-svoa): 70-day washout
- Biosimilars
- Byooviz (ranibizumab-nuna): 30-day washout
- Cimerli (ranibizumab-eqrn): 30-day washout
- Pavblu (aflibercept-ayyh): 60-day washout
- Afqlir (aflibercept): 60-day washout
- Enzeevu (aflibercept-abzv): 60-day washout
- Ahzantive (aflibercept-mrbb): 60-day washout
- Demonstrates the ability to instill eye drops (by the subject or caregiver) in the study eye, express willingness to comply with the dosing regimen, and commit to attending all study visits.
- Understands and voluntarily signs an informed consent form.
- Hormonal contraception (i.e., birth control pills, injected hormones, dermal patch, or vaginal ring),
- intrauterine device,
- barrier methods (diaphragm, condom) with spermicide, or
- surgical sterilization (hysterectomy or tubal ligation).
What rules you out
- Uncontrolled hypertension (systolic \> 180 mmHg or diastolic \> 100 mmHg) despite optimal medical regimen
- Uncontrolled diabetes (HbA1c \> 12.0%)
- Total bilirubin \> 1.5 × Upper Limit of Normal (ULN)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2.5 × ULN
- Prothrombin time (PT) \> 1.5 × ULN
- Hemoglobin (Hb) \< 10 g/dL (male); Hb \< 9 g/dL (female)
- Platelets \< 100 × 103 µL
- Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m2
- Positive results for Human Immunodeficiency Virus (HIV) or Hepatitis B or C viruses.
- Other clinically significant abnormal lab values per Investigator's judgement.
- Subject who has a medical condition that, in the opinion of the Investigator, would preclude participation in the study (e.g., unstable medical status including psychiatric disorder, cardiovascular disease, poor...
- History of stroke or myocardial infarction (MI) within 6 months prior to Screening.
- Subject who has had major surgery within 3 months prior to Screening.
- Pregnant or breastfeeding or intending to become pregnant during the study.
- Subject with known hypersensitivity to any active substance or excipients of the investigational product, fluorescein, dilating eye drops, or any of the anesthetic and antimicrobial drops.
- Treatment with investigational therapy or participation in any other type of treatment trial within 30 days before Screening.
- Subject who has a history of AMD treatment in the study eye with Beovu® (brolucizumab) or photodynamic therapy.
- CNV in the study eye secondary to other causes or subject who has an ocular condition (other than AMD) that, in the opinion of the Investigator, may limit visual acuity improvement during the course of the study (e.g...
- Media opacities or abnormalities in the study eye that would preclude visualization of the retina.
- Subject who has a history of retinal detachment or retinal detachment repair surgery in the study eye, unless otherwise allowed at the discretion of the Investigator.
- Subject who has a history of yttrium aluminum garnet (YAG) capsulotomy performed within 2 months prior to randomization in the study eye.
- Uncontrolled glaucoma in either eye (IOP \> 25 mmHg despite treatment with a standard regimen of antiglaucoma medications), with exceptions allowed at the Investigator's discretion.
- Any active intraocular or periocular infection or active intraocular inflammation (e.g., infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in either eye on Screening.
- Subject who has a history of vitrectomy in the study eye, unless otherwise allowed at the discretion of the Investigator.
- Subject who has a history of ocular surgery in the study eye (including cataract extraction, any intraocular surgery, etc.) within 3 months prior to Screening or anticipated within the next 6 months following...
- Subject who has any history of intraocular inflammation in either eye, other than what would be expected in the normal post-operative course following prior routine ocular surgery such as cataract surgery.
- Subject who has other retinal pathologies in the study eye that would interfere with vision, such as evidence of diabetic macular edema or diabetic retinopathy (defined as more than one microaneurysm).
- Non-study eye with a BCVA worse than 20 letters at Screening using ETDRS testing.
- Total lesion size \>12 disc areas (30.5 mm2), including blood, scar, and neovascularization, in the study eye as assessed by FA.
- Scar, fibrosis, or atrophy involving the center of the fovea in the study eye, as assessed by FA.
The study team makes the final eligibility decision.
Where it is enrolling
- Bonita Springs, Florida, United States
- Tulsa, Oklahoma, United States
- Erie, Pennsylvania, United States
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, but 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, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bonita Springs, Florida, United States; Tulsa, Oklahoma, United States; Erie, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.