Refine your search

Search Results within category "Eyes & Vision"

Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.

Search all categories

Suggestions within category "Eyes & Vision"


2 Study Matches

REC 0/0559 Eye Drops for Treatment of Moderate and Severe Neurotrophic Keratitis in Adult Patients

A phase 2 study, aiming to evaluate the efficacy, safety and pharmacokinetics of REC 0/0559 in treatment of Neurotrophic Keratitis in Adult Patient in Europe and United States of America.
Evan Warner
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT04276558
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
1. Have read, understood, and signed the informed consent form (ICF). 2. Be a male or female aged ≥18 years at the time of ICF signature. 3. Have stage 2 moderate (PED) or stage 3 severe (corneal ulcer) NK involving only 1 eye (study eye) and of at least 2 weeks duration. Patients with Stage 1 NK in the fellow eye can be enrolled. for the study eye 4. Have no objective clinical evidence of improvement in the PED or corneal ulceration within the 2 weeks before the screening visit despite use of conventional non-surgical treatment (eg, nonpreserved ocular lubricants, nonpreserved topical antibiotics, oral doxycycline, patching, serum tears, and/or therapeutic contact lenses) as determined by the investigator's or referring physician's medical record. 5. Have decreased corneal sensitivity (≤ 4 cm using the Cochet-Bonnet aesthesiometer) within the area of the PED or corneal ulcer and outside of the area of the defect in at least one corneal quadrant. 6. Have a BCDVA score ≤ 75 ETDRS letters in the study eye, due to NK.
Exclusion Criteria:
1. Have participated in any clinical trial with an investigational drug/device within 2 months before the Screening Visit and throughout the study duration. 2. Have a known hypersensitivity to one of the components of the study drug or procedural medications (eg, fluorescein), including to a compound chemically related to MT8 3. Have a presence or history of any ocular or systemic disorder or condition that might hinder the efficacy of the study treatment or its evaluation, could possibly interfere with the interpretation of study results, or could be judged by the investigator to be incompatible with the study visit schedule or conduct (eg, progressive or degenerative corneal or retinal conditions, lagophthalmos, uveitis, optic neuritis, poorly controlled diabetes, autoimmune disease, systemic infection, neoplastic diseases), or that may compromise the safety of the patient. 4. Have a significant history of alcohol abuse or drug/solvent abuse 5. Be unwilling to comply with any study assessments or procedures. 6. Be a woman who is pregnant, nursing or planning a pregnancy. 7. Be a woman of childbearing potential not using a highly effective method of birth control. 8. Be a male patient who is not permanently sterile and who is not willing to use condoms during the study and for 4 weeks after the end of study treatment. For the study eye: 9. Have any active ocular infection (bacterial, viral, fungal or protozoal) or active inflammation not related to NK in the study eye. 10. Have any other ocular disease requiring topical ocular treatment in the study eye during the course of the study treatment period, except for glaucoma if treated by preservative-free eye drop (single-agent treatment, once daily, stable regimen 4 weeks before screening and during the study), 11. Receive topical ophthalmological treatments other than the study drug provided by the study Sponsor and the treatments allowed by the study protocol (eg, preservative-free artificial tears; preservative-free eye drop (single-agent treatment, once daily, stable regimen 4 weeks before screening and during the study) for glaucoma; topical antibiotics; other than tetracycline). 12. Have severe blepharitis and/or severe meibomian gland disease in the study eye. 13. Have severe vision loss in the study eye with no potential for visual improvement in the opinion of the investigator as a result of the study treatment. 14. Have evidence of corneal ulceration/melting involving the posterior third of the corneal stroma, or perforation in the study eye. 15. Have a history of any ocular surgery (including laser or refractive surgical procedures) within 3 months before the Screening Visit in the study eye. An exception to the preceding statement will be allowed if the ocular surgery is considered to be the cause of the Stage 2 or 3 NK. 16. Have a history of corneal transplantation in the study eye, except if performed to treat NK and at least 6 months prior screening. 17. Have had prior surgical procedures for the treatment of NK (eg, tarsorrhaphy, conjunctival flap, etc.) except AMT, if at least 2 wks after the membrane has disappeared within the area of the PED or corneal ulcer (and at least 6 weeks after the procedure) in the study eye. 18. Use therapeutic contact lenses or wear contact lenses for refractive correction during the study treatment periods in the eye(s) with NK. 19. Have an anticipated need for punctal occlusion during the study treatment period. Patients with punctal occlusion or punctal plugs inserted before the study are eligible for enrolment provided that the punctal occlusion is maintained during the study. 20. Have an uncontrolled glaucoma at the Screening Visit. (Patients suffering from glaucoma requiring ophthalmic drops for topical treatment at the Screening Visit or during the study are not eligible, except if the ophthalmic drops is a preservative-free treatment administered maximum once daily as a single-agent treatment and at a stable regimen 4 weeks before screening and at the same dose during the study. Patients treated with oral intraocular pressure-lowering drugs at the Screening Visit and during the study may be enrolled if their glaucoma status is assessed as stable and controlled. For the fellow eye 21. Have Stage 2 or 3 NK or perforation. For any eye: 22. Have a history of ocular cancer. 23. Have had prior treatment with Oxervate™
Neurotrophic Keratitis, Other, Eye & Vision, Infections, Immune System & Allergies
  Share Study Information
  Contact by Email
  See more information

Vamikibart in Participants With Uveitic Macular Edema (Sandcat)

This study will assess the efficacy and safety of vamikibart in participants with uveitic macular edema.
Laura Kopplin
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT05642325
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:

• Female participants: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception as defined by the protocol
• Diagnosis of macular edema associated with non-infectious uveitis (NIU)
• Diagnosis of active or inactive, acute, or chronic NIU of any etiology and of any anatomical type (anterior, intermediate, posterior, panuveitis)
• BCVA letter score of 73 to 19 letters (inclusive) on Early Treatment Diabetic Retinopathy Study (EDTRS)-like charts
Exclusion Criteria:

• Evidence of active or latent syphilis infection
• Evidence of active or latent tuberculosis infection and/or positive tuberculosis assay, or previous or current HIV diagnosis
• Serious acute or chronic medical or psychiatric illness
• History of major ocular and non-ocular surgical procedures
• Uncontrolled IOP or glaucoma or chronic hypotony
• Any anatomical changes or media opacity in the study eye preventing evaluation of retina, vitreous, and capture of study images
• Prior use of IVT biologics including anti-VEGFs less than 2-4 months prior to Day 1; received IVT Methotrexate within 4 months prior to Day 1
• Prior macular laser therapy, cataract surgery within 6 months and laser capsulotomy within 3 months of Day 1
• Topical corticosteroids and/or topical NSAID > 3 drops per day in the 14 days prior to Day 1 (D1); intraocular or periocular corticosteroid injections in the 2 months prior to D1; subconjunctival corticosteroid injection within 1 month prior to Day 1; an OZURDEX implant in the 4 months prior to D1; YUTIQ, RETISERT or ILUVIEN implant in the 3 years prior to D1
• Diagnosis of macular edema due to any cause other than NIU
• Any major ocular conditions that may require medical or surgical intervention during the study period to prevent vision loss
Uveitic Macular Edema, Other, Eye & Vision, Infections, Immune System & Allergies
  Share Study Information
  Contact by Email
  Contact by Phone
  See more information