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Ongoing Clinical Trials for Eye Disorders

This article provides detailed information about 7 ongoing clinical trials investigating various eye disorders, including Thyroid Eye Disease, Diabetic Macular Edema, vision impairments, glaucoma, ocular hypertension, and wet age-related macular degeneration. These trials are being conducted across multiple countries in Europe, testing treatments such as Linsitinib, Dexamethasone implants, Zolpidem, combination eye drops, OPT-302 with Aflibercept, and OPT-302 with Ranibizumab.

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Study on Linsitinib for Patients with Active, Moderate to Severe Thyroid Eye Disease

This trial is investigating Linsitinib, a film-coated tablet, for patients with active, moderate to severe Thyroid Eye Disease. The condition causes inflammation and swelling around the eyes, leading to symptoms such as bulging eyes, discomfort, and vision problems.

Main inclusion criteria: Participants must have completed a previous 24-week study called VGN-TED-301 and should either not have shown improvement in eye bulging or have shown improvement but then worsened during follow-up. Participants must not have received any treatment for the condition since the end of the previous study. Thyroid levels should be stable or have only mild imbalances. Both men and women can participate.

Main exclusion criteria: Patients who have not completed Week 24 of the lead-in study VGN-TED-301, those with medical conditions that could interfere with the study results, patients not within the specified age range, and those from vulnerable populations cannot participate.

Trial focus: The study aims to evaluate the effectiveness and safety of Linsitinib in reducing eye bulging (proptosis) over a 24-week period. Participants will take either Linsitinib at 75 mg or a placebo and will have regular follow-up visits to monitor changes in their condition.

Investigational drug: Linsitinib is a tyrosine kinase inhibitor being studied for its potential to reduce eye protrusion in patients with moderate to severe Thyroid Eye Disease by inhibiting certain proteins involved in cell growth and survival.

Study on the Effectiveness of Dexamethasone Implant for Patients with Diabetic Macular Edema

This trial is focused on Diabetic Macular Edema, a condition that affects the eyes of people with diabetes and can lead to vision problems. The study uses an implant called Ozurdex, which releases Dexamethasone directly into the eye to reduce swelling and improve vision.

Main inclusion criteria: Patients must be over 40 years old, have significant diabetic macular edema with a central macular thickness of at least 285 micrometers, and have visual acuity between 20/32 and 20/230. The eye should not have received any previous drug treatment, patients must have had cataract surgery at least 3 months prior, HbA1c levels must be less than 10%, and blood pressure must be less than 160/95 mmHg.

Main exclusion criteria: Patients with any other eye disease that could affect vision, those who have had eye surgery in the last 3 months, those allergic to study medication ingredients, pregnant or breastfeeding women, patients with uncontrolled diabetes or severe heart problems, and those currently participating in another clinical trial are excluded.

Trial focus: The study evaluates the effectiveness of the Ozurdex intravitreal implant over one year, tracking improvements in visual acuity and monitoring the number of injections needed. The study will last up to two years with regular follow-up visits.

Investigational drug: Ozurdex is an intravitreal implant containing dexamethasone, a corticosteroid that reduces inflammation and swelling in the retina to improve visual acuity in patients with diabetic macular edema.

Study on Zolpidem’s Effects in Patients with Vision Impairments, Disorders of Consciousness, and Neurotypical Volunteers

This trial explores how Zolpidem, typically used to help with sleep problems, affects different groups of people, including patients with disorders of consciousness, individuals with vision impairments, and neurotypical volunteers. Some participants experience unusual reactions such as regaining consciousness or temporarily recovering vision.

Main inclusion criteria: For patients with disorders of consciousness, participants must be over 18 years old, more than 28 days post-injury, have a diagnosis of consciousness disorder, and have stable vital signs. For neurotypical volunteers, participants must be 18 years or older and in good health. For patients with vision impairments, participants must be 18 or older and have partial or total acquired vision impairments confirmed by a neuro-ophthalmologist.

Main exclusion criteria: Patients not between 18 and 65 years, pregnant or breastfeeding women, those with severe allergic reactions to study medication, patients taking interfering medications, those with severe liver or kidney disease, history of drug or alcohol abuse, unstable psychiatric disorders, recent participation in another trial, and those unable to comply with study procedures are excluded.

Trial focus: The study aims to understand the unexpected responses some people have to Zolpidem and to improve personalized care. Researchers will monitor consciousness levels, alertness, cognitive performance, and brain activity using high-density electroencephalography.

Investigational drug: Zolpidem is a sedative-hypnotic medication that enhances GABA activity in the brain. In this trial, it is being studied for its unique effects on consciousness and vision in certain patient populations.

Study Comparing Brimonidine and Timolol Eye Drops for Patients with Open-Angle Glaucoma or Ocular Hypertension

This trial compares a new generic formulation of eye drops containing brimonidine and timolol with the marketed version called Combigan. Both treatments are designed to lower eye pressure in patients with open-angle glaucoma or ocular hypertension.

Main inclusion criteria: Participants must be at least 18 years old, have a diagnosis of open-angle glaucoma or ocular hypertension in one or both eyes, have an average eye pressure between 22 and 35 mmHg, not have used eye pressure-lowering drugs for at least 4 weeks before the study, have best-corrected visual acuity of at least 20/100, and have controlled blood pressure.

Main exclusion criteria: Patients with other eye diseases besides open-angle glaucoma or ocular hypertension, those who have had eye surgery in the past three months, people allergic to study medications, those using medications that might interfere with treatment, pregnant or breastfeeding women, individuals with severe health conditions, recent participants in another trial, and those unable to follow study procedures are excluded.

Trial focus: The study evaluates whether the new generic eye drops are as effective and well-tolerated as Combigan over 12 weeks. Eye pressure is monitored at different times of the day to assess treatment effectiveness.

Investigational drug: The generic formulation contains brimonidine 0.2% and timolol 0.5%. Brimonidine decreases fluid production and increases outflow in the eye, while timolol reduces fluid production. Both are ophthalmic glaucoma agents.

Study of OPT-302 and Aflibercept for Patients with Wet Age-related Macular Degeneration

This trial is testing a combination treatment of OPT-302 and aflibercept for neovascular age-related macular degeneration (wet AMD), a condition that causes vision loss in older adults. The study aims to determine if adding OPT-302 to aflibercept can improve outcomes compared to aflibercept alone.

Main inclusion criteria: Participants must be at least 50 years old and have an active subfoveal or juxtafoveal CNV lesion with foveal involvement in the study eye. Visual acuity must be between 60 and 25 letters on the ETDRS BCVA scale.

Main exclusion criteria: Patients with any other eye diseases affecting study results, those who have had eye surgery in the last three months, patients currently receiving or recently receiving certain eye treatments, those with severe allergic reactions to study medications, uncontrolled high blood pressure, serious health conditions, pregnant or breastfeeding women, participants in another trial, and those unable to comply with study procedures are excluded.

Trial focus: The study evaluates the effectiveness and safety of the combination treatment over 96 weeks. Participants receive intravitreal injections, and vision is monitored regularly to assess changes in visual acuity and eye health.

Investigational drugs: OPT-302 (2.0 mg) is an anti-angiogenic agent that blocks proteins contributing to abnormal blood vessel growth. Aflibercept (2.0 mg) is a VEGF inhibitor that prevents vision loss by blocking proteins promoting blood vessel formation in the eye.

Study on the Effectiveness of OPT-302 and Ranibizumab for Patients with Wet Age-related Macular Degeneration

This trial investigates a combination treatment of OPT-302 and ranibizumab for neovascular age-related macular degeneration (wet AMD). The study aims to evaluate whether the combination is more effective than ranibizumab alone.

Main inclusion criteria: Participants must be at least 50 years old and have an active subfoveal or juxtafoveal CNV lesion with foveal involvement in the study eye. Visual acuity must be between 60 and 25 letters on the ETDRS BCVA scale.

Main exclusion criteria: Patients with other eye diseases affecting study results, those who have had eye surgery within the last three months, patients currently receiving or recently receiving certain eye treatments, those with severe allergic reactions to study medications, uncontrolled high blood pressure, serious health conditions, pregnant or breastfeeding women, participants in another trial, history of drug or alcohol abuse, and those unable to comply with study procedures are excluded.

Trial focus: The study evaluates the effectiveness and safety of the combination treatment over approximately 52 weeks. Participants receive intravitreal injections, and regular assessments monitor changes in visual acuity and eye health.

Investigational drugs: OPT-302 (2.0 mg) is an anti-angiogenic agent that blocks proteins contributing to abnormal blood vessel growth. Ranibizumab (0.5 mg) is a monoclonal antibody fragment that targets VEGF to prevent vision loss by inhibiting abnormal blood vessel growth in the eye.

Study on the Safety and Efficacy of Linsitinib for Patients with Active, Moderate to Severe Thyroid Eye Disease

This trial evaluates Linsitinib, a film-coated tablet, for its safety and effectiveness in treating active, moderate to severe Thyroid Eye Disease. Participants will be randomly assigned to receive either Linsitinib or a placebo over 24 weeks.

Main inclusion criteria: Participants must have a clinical diagnosis of Graves’ Disease or autoimmune Hashimoto’s thyroiditis with active moderate to severe TED. The Clinical Activity Score must be 4 or more for the most affected eye. TED should not be sight-threatening but should have a noticeable impact on daily life, and the diagnosis should have been made within 12 months before screening. Participants must be euthyroid or have mild hypothyroidism or hyperthyroidism.

Main exclusion criteria: The trial data does not provide specific exclusion criteria, but standard exclusions typically apply.

Trial focus: The study assesses the proptosis responder rate at week 24 as the primary goal. Secondary evaluations include changes in proptosis measurement, Clinical Activity Scale scores, and quality of life measured by the Graves’ Ophthalmopathy Quality of Life questionnaire.

Investigational drug: Linsitinib is a tyrosine kinase inhibitor administered orally. It works by blocking enzymes involved in cell signaling pathways to reduce inflammation and tissue expansion associated with TED.

Summary

These seven clinical trials represent a diverse range of investigations into various eye disorders. A significant concentration of trials focuses on wet age-related macular degeneration, with studies in multiple European countries including Bulgaria, Hungary, Croatia, Spain, Italy, Poland, Netherlands, Estonia, Latvia, Austria, Czechia, Greece, France, Germany, Slovakia, and Lithuania. The OPT-302 combination studies are particularly widespread across Europe.

Two trials are investigating Linsitinib for Thyroid Eye Disease, both conducted in Spain and Italy. These studies are exploring the medication’s potential to reduce eye bulging and improve symptoms in patients with moderate to severe disease.

France is uniquely hosting a trial on Dexamethasone implants for Diabetic Macular Edema, while Greece is conducting research on combination eye drops for glaucoma and ocular hypertension. Germany and Belgium are collaborating on an unusual trial examining Zolpidem’s unexpected effects in patients with vision impairments and disorders of consciousness.

The trials employ various treatment approaches, from intravitreal injections to oral medications and eye implants. Many of the wet AMD trials are investigating combination therapies, reflecting current research trends toward optimizing treatment outcomes through multiple therapeutic pathways.

Ongoing Clinical Trials on Eye disorder

  • A Study Testing How Well Faricimab Works in Patients with Subretinal Hyperreflective Material Associated with Neovascular Membranes in the Eye

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