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About Clinical Trials

A clinical study is a research study performed in people with the aim of evaluating a medical, surgical or behavioral intervention. They are the primary way that researchers find out if a treatment, like a drug or medical device (like a pacemaker) is safe and effective in people. They are also done to see if new treatments work better and/or are less harmful than the standard treatment.

Clinical trials of drugs advance through four phases. The FDA typically requires phase I, II, III trials to be conducted to determine if the drug can be approved for use.

A Phase I trial – tests an experimental treatment on a small group of often healthy people (20-80). Before a Phase 1 trial can be done, the study drug has been tested on animals and is found to be safe. In a Phase 1 trial the drug is tested for the first time in humans. For this reason, a very small dose is tested first, often on healthy people. The dose is slowly increased to make sure that there are no significant side effects until a dose where a treatment response is seen.

A Phase II trial – involves more people (100 to 300). While the emphasis in Phase I is on safety, the emphasis in Phase II is on effectiveness. This phase aims to obtain preliminary data on whether the drug works in people who have a certain disease or condition. These trials also continue to study safety, including short-term side effects. This phase can last several years.

A Phase III trial –gathers more information about safety and effectiveness, studying different populations and different dosages, using the drug in combination with other drugs. The number of subjects usually ranges from several hundred to about 3,000 people. If the FDA agrees that the trial results are positive, it will approve the experimental drug or device.

A Phase IV trial– is for drugs or devices that the FDA has already approved. A device or drug’s effectiveness and safety are monitored in large, diverse populations. Sometimes, the side effects of a drug may not become clear until more people have taken it over a longer period of time.

There are many reasons why people choose to join a clinical trial. Some join a trial because the treatments they have tried for their health problem did not work. Others participate because there is no treatment for their health problem. By being part of a clinical trial, participants may find out about new treatments before they are widely available

Other reasons you want to consider when deciding if you want to be in a clinical study for your retinal diseases are:

  1. Medication is covered for the study eye that is being investigated. Many times, the other eye is also treated and covered by the study.
  2. Most studies offer a stipend ranging from $25 – $100 per visit
  3. Most studies will provide travel reimbursement for your visits.
  1. Study staff explain the trial in detail and gather more information about you.
  2. Once you have had all your questions answered and agree to participate, you sign an informed consent form.
  3. You are screened to make sure you qualify for the trial.
  4. If accepted into the trial, you schedule a first visit (called the “baseline” visit). The researchers conduct tests and take different scans during this visit.
  5. You are randomly assigned to a treatment or control group.
  6. You and your family members follow the trial procedures and report any issues or concerns to researchers.
  7. You may visit the research site at regularly scheduled times for evaluations and discussions with staff. At these visits, the research team collects information about effects of the intervention and your safety and well-being.
  8. You continue to see your regular physician for usual health care throughout the study.

Currently Enrolling

A PHASE IIIB/IV, MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO INVESTIGATE FARICIMAB (RO6867461) TREATMENT RESPONSE IN TREATMENT-NAÏVE, UNDERREPRESENTED PATIENTS WITH DIABETIC MACULAR EDEMA

Length of study – 61 weeks

Inclusion Criteria : Correct ethnicity; Black/African American, Hispanic/Latino American, or Native American/Alaska Native/Native Hawaiian or other Pacific Islander, 18 y.o or older, treatment naïve(meaning on previous laser or intravitreal injections), diagnosed with DM type I or II that is being treated with medication, Diagnosed with DME(diabetic macula edema) – >325 CST/OCT, have a hemoglobin A1C<=10%, BCVA ETDRS score 20-73(which is 20/20 to 20/100), clear ocular media, female not pregnant.

Exclusion Criteria: High risk PDR/VH/NVE/RI, Uveitis, any Glaucoma surgery, Cataract surgery within last 3 months, cancer or CVA within past year, uncontrolled blood pressure >180/100, pregnant or breastfeeding, renal failure, NO laser or IV injections or use of corticosteroids, Non-study eye- hand motion vision or blind.

For this study there is 1 arm of treatment:

  • Intravitreal Faricimab (which is FDA approved for DME) , 1 injection every 4 weeks up to week 20 then 1 injection every 8 weeks till week 52.

Link for the study: https://www.youtube.com/watch?v=gCEgAyYGz3o

A PHASE IV, RANDOMIZED, MASKED, CONTROLLED STUDY OF INTRAVITREAL ILUVIEN IMPLANT AS BASELINE THERAPY IN PATIENTS WITH EARLY DIABETIC MACULAR EDEMA (DME)

This is a randomized masked, controlled study of intravitreal Iluvien Implant as baseline therapy in patients with early DME.

Objectives: To assess the efficacy of ILUVIEN as baseline therapy in patients with early DME, To assess the effects of ILUVIEN on patient reported outcomes(PRO) of visual functioning and quality of life, and to assess the safety and tolerability of ILUVIEN and Aflibercept combination in DME patients.

Length of study – 18 months

Inclusion Criteria : 18y.o or older, diagnosed with DM type I or II, must have CI-DME of CST >=350 micrometers, BCVA <80 ETDRS & > 35 ETDRS, females not pregnant and use contraception.

Exclusion Criteria: PDR, OHT or C/D ratio >.7, have other conditions that can cause Macular edema, PRP laser, Focal laser (but focal laser outside macula is allowed), IVT/periocular steroids, IVT Eylea, Avastin, Lucentis or any other injection in study eye < 12 months prior, anterior IOL’s, VMT or Interface abnormalities, patients who take corticosteroids daily.

For this study there are 2 arms of treatment:

  • Intravitreal Iluvien implant followed by supplemental intravitreal aflibercept given as Needed per protocol criteria.
  • Intravitreal Aflibercept every 4 weeks X 5 doses followed by supplemental IV Aflibercept injections given as needed.

This is a Phase 2 study to evaluate the safety and efficacy of OPL-0401 in patients with non-proliferative diabetic retinopathy.

Spectra is a clinical research study for people with mild, moderate, or severe Diabetic Retinopathy. The study is researching OPL-0401, a study medication that may help prevent further eye damage from Diabetic Retinopathy.

Participation in the Spectra study lasts about 6 months. During the study, participants take 2 capsules of OPL-0401 or placebo(contains no active ingredients) every morning and 2 more at night. Study participants are also asked to visit the study clinic a total of ten times for eye exams, blood and urine tests, and other study health assessments.

The purpose of this study is to learn about the effects and safety of OPL-0401 in participants with NPDR. The expectation is that this study will provide a better understanding of the benefits and risks for OPL-0401 in participants, as well as provide a recommended dose of OPL-0401 that can be used in future studies. The aim of this study is to show that OPL-0401 may prevent the progression to vision threatening disease. The other aims of the study are to learn more about the safety of OPL-0401 and any of the side effects that might occur following OPL-0401 treatment and to understand how much OPL-0401 is in your blood at various times during study treatment.

Inclusion; 18 years of age or older, diagnosed with mild to moderate or moderate to severe diabetic retinopathy (NPDR), BCVA >=69 or 20/40 or better, capable of giving signed informed consent, and for females- women not of childbearing potential or agrees to follow the contraceptive guidance.

Exclusion; Body mass index >40 kg/m2, significant weight loss over the 6 months prior to first dose, uncontrolled diabetes mellitus with hemoglobin A1c >10%, initiation of new antidiabetic medication within 3 months prior to randomization, history of any vitreous surgery, PDR/ NVE/ PRP, uncontrolled glaucoma >=25

A MULTICENTER, NON-RANDOMIZED, OPEN-LABEL, MULTIPLE ASCENDING DOSE STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF RO7497372 FOLLOWING INTRAVITREAL ADMINISTRATION IN PARTICIPANTS WITH DIABETIC MACULAR EDEMA

Part 2 of a Phase I, multipart, multicenter study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of R07497372 following intravitreal administration in participants with diabetic macular edema.

The purpose of this research study is to examine the effects,of two doses of RO7497372 (low dose and high dose.

A phase I clinical trial that is investigation the effects of “R07497372” in people with diabetic macular edema(DME). “R07497372” is a drug which inhibits two targets at the same time – one target is a contributor to inflammation and the other a contributor to vessel growth and fluid accumulation in the retina.

Length of study- 36 weeks

Inclusion Criteria:
The study is available to people over 18 years of age who have diabetes, type I or type II, for which they take oral or injectable medication or are on diet control. Diagnosed with Macular thickening secondary to DME involving the center of the fovea with central subfield thickness (CST) ≥ 325, BCVA primarily due to DME with ETDRS score of 78 to 19 letters (both inclusive)

Exclusion Criteria:
Proliferative Diabetic Retinopathy, uncontrolled glaucoma, aphakia or intraocular lens outside the capsular bag, any active inflammation in the eye, Uncontrolled BP, HbA1c>12

Patients are assigned into a group depending on the Cohort that is enrolling. Each group will receive a different dose. A patient will receive a total of 3 injections, spaced 4 weeks apart.

RGX-314-3101-Ascent study (1 year study that uses Eylea as the control medication)

This is a randomized, partially masked, controlled, phase 3 clinical study to evaluate the efficacy and safety of RGX-314 Gene Therapy in participants with neovascular Age Related Macular Degeneration or wet AMD. This is a 54 week trial that is comparing Aflibercept(Eylea) to RGX-314.

RGX-314 is an investigational adeno-associated virus(AAV) gene therapy being developed as a potential treatment for patients with neovascular age-related macular degeneration (nAMD, also known as “wet” age-related macular degeneration [AMD]) and for patients with diabetic retinopathy

This is a randomized, partially masked, controlled, phase 2b/3 clinical study to evaluate the efficacy and safety of RGX-314 Gene Therapy in participants with neovascular Age Related Macular Degeneration or wet AMD. The purpose of this study is to evaluate whether two different doses of RGX-314 help improve or preserve vision compared to Lucentis®. In this study, you will either receive RGX-314 or only Lucentis®.  This is a 98 week long study.

Treatment of neovascular AMD (nAMD) with anti-VEGF therapy is highly effective but is associated with considerable treatment burden and cost for patients and the healthcare system. One of the principal barriers to reducing burden and cost is that both the optimal timing and the optimal number of injections needed to achieve best visual acuity and disease control for any one person are unknown. At present, there are several algorithms that modestly reduce treatment burden, but at the expense of overtreatment in some patients and less optimal disease control in others. The lack of precision in disease management may be due in part to the low frequency of disease monitoring, which typically occurs every one to two months by standard OCT imaging during an office visit. Home OCT imaging allows daily disease activity monitoring and the possibility of a tailored and more personalized approach to managing neovascular AMD. Thid is a randomized clinical trial that compares visual acuity outcomes, and visit and injection frequencies, obtained using a Home OCT-guided treatment strategy versus outcomes obtained using Treat and Extend, the treatment algorithm widely perceived to be the most common regimen in clinical practice today.

DRCR protocol AM: Randomized Trial Comparing Immediate versus Deferred Surgery for Symptomatic Epiretinal Membranes

Vitrectomy to remove an epiretinal membrane (ERM) is one of the most common procedures performed by retinal surgeons. Patients who present with significant macular changes on optical coherence tomography (OCT) but relatively good vision are often advised to defer surgery until vision declines to 20/40 or worse. However, it is unknown if delaying surgery, which allows the foveal architecture to remain compromised and potentially to deteriorate, results in worse visual acuity outcomes than if surgery is performed earlier. In addition, there is a need to better understand predictors of outcomes when surgery is performed and predictors of progression when surgery is deferred. Finally, one of the most common presenting symptoms from an ERM is distortion or metamorphopsia. There are several objective measures of metamorphopsia, but none have been employed to evaluate ERMs in a randomized clinical trial (RCT) and their usefulness is unknown. The purposes of this study are to better understand the optimal timing of surgery to produce the best visual result, to better understand predictors of outcomes in those who undergo surgery and predictors of progression in those whose are observed, and to better characterize and evaluate the usefulness of metamorphopsia and reading speed measures.

“ASTELLAS-REVEAL:  A NON-INTERVENTIONAL, OBSERVATIONAL STUDY TO EVALUATE TREATMENT PATTERNS AND SAFETY OF AVACINCAPTAD PEGOL (ACP/IZERVAY™) IN ROUTINE CLINICAL PRACTICE IN PATIENTS WITH GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION.

If you decide to take part in this research study, the general procedures include collection of your medical history, medications and procedures from approximately 5 years before starting treatment with IZERVAYTM and during treatment follow-up. At some visits, you will be asked questions about your vision.

This study is being done to better understand patient experiences, treatment, management and safety of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) when treated with IZERVAYTM eye injections.

Your participation in the study will depend on how long you are treated with IZERVAYTM but will not be longer than 3-5 years from when you sign the consent form.  Your participation may continue even if you end treatment with IZERVAYTM.

Prior Studies

YUTIQ – calm (EYP-YUT-0001)

This is a Phase IV retrospective registry study to collect Real-World Data on YUTIQ, a Fluocinolone Acetonide Intravitreal Implant, for the treatments of chronic non-infectious Uveitis affecting the posterior segment.

This is a retrospective study, a database will be compiled of up to 500 patients who have been treated with YUTIQ at up to 50 sites. Routine standard of care ocular assessments (eg, visual acuity [VA], intraocular pressure [IOP], measurements from optical coherence tomography [OCT]), and adverse events may be collected from routine visits over 5 years.

Inclusion; patients with chronic, non-infectious uveitis affecting the posterior segment of the eye, and men /women >= 18 years old.

Exclusion; patients with contraindications per US prescribing information, eg-active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva. Patients with known hypersensitivity to any components of YUTIQ. Pregnant and/or nursing women. Concurrent participation in another study involving an investigational drug or device.

OPI-APXDR-201 ZETA-1 – Randomized, Placebo-Controlled, Double-Masked Study of the Safety and Efficacy of Orally Administered APX3330 in Subjects with Moderately Severe to Severe Non-Proliferative Diabetic Retinopathy or Mild Proliferative Diabetic Retinopathy. Closed

New Day Study – A phase IV, randomized, masked, controlled study of Intravitreal Iluvien Implant as baseline therapy in patients with Early Diabetic Macular Edema (DME). Closed

VALO – OPL-0401-201 – SPECTRA STUDY – This is a Phase 2 study to evaluate the safety and efficacy of OPL-0401 in patients with non-proliferative diabetic retinopathy. Closed

PREGONDA – BP44175 STUDY – A multicenter, non-randomized, open-label, multiple ascending dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO7497372 following intravitreal administration in participants with Diabetic Macular Edema. Closed

TELESCOPE: A STUDY TO IDENTIFY THE LOCATION OF ATROPHY AND GENETICALLY DEFINE SUBJECTS WITH GEOGRAPHIC ATROPHY SECONDARY TO AGERELATED MACULAR DEGENERATION.

HORIZON: A PHASE II, OPEN-LABEL, OUTCOMES-ASSESSOR MASKED, MULTICENTRE, RANDOMISED, CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF TWO DOSES OF GT005 ADMINISTERED AS A SINGLE SUBRETINAL INJECTION IN SUBJECTS WITH GEOGRAPHIC ATROPHY SECONDARY TO DRY AGE-RELATED MACULAR DEGENERATION. Closed

EXPLORE: A PHASE 2, OUTCOMES ASSESSOR-MASKED, MULTICENTRE, RANDOMISED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF TWO DOSES OF GT005 ADMINISTERED AS A SINGLE SUBRETINAL INJECTION IN SUBJECTS WITH GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION. Closed

LUGANO STUDY; EYP-1901-301

Title:  A Phase 3, Multicenter, Prospective, Randomized, Double-Masked, Parallel-Group Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept in Subjects with Wet AMD. Closed

Acronyms

AMD – age-related macular degeneration

nAMD – neovascular age-related macular degeneration

CNV – choroidal neovascularization

NPDR – non-proliferative diabetic retinopathy

PDR – proliferative diabetic retinopathy

DME – diabetic macular edema

CI-DME – center involved diabetic macular edema

NVE – neovascularization elsewhere

PRP – panretinal photocoagulation

DM – diabetes mellitus

IVT – intravitreal triamcinolone

VMT – vitreomacular traction

VH – vitreous hemorrhage

RI – rubeosis iridis

C/D ratio – cup to disc raio

OHT – ocular hypertension

IOL – intraocular lens

BCVA – best corrected visual acuity

ETDRS – early treatment diabetic retinopathy study – this is a standardized research chart

CST – central subfield thickness

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