Currently Enrolling Studies

PEDIG ATS-22

A Randomized Trial to Evaluate Sequential vs Simultaneous Spectacles plus Patching for Amblyopia in Children 3 to <13 Years Old

• Age 3 to <13 years at the time of randomization
• No previous treatment for amblyopia
• No previous spectacle or contact lens wear for more than a total of 24 hours
• Amblyopia associated with anisometropia, strabismus, or both
• Investigator is willing to prescribe spectacle wear followed sequentially by patching or simultaneous spectacles and patching treatment per protocol
• VA in the amblyopic eye approximately 20/40 to 20/200 (0.26 to 1.04 log MAR inclusive, 33 to 72 letters inclusive)
  • Age-normal VA in the fellow eye:
    •  3 years: approximately 20/50 or better, ≤ 0.44 log MAR, ≥ 63 letters
    •  4 years: approximately 20/40 or better, ≤ 0.34 log MAR, ≥ 68 letters 
    •  5-6 years: approximately 20/32 or better, ≤ 0.24 log MAR, ≥ 73 letters
    • 7-12 years: approximately 20/25 or better, ≤ 0.14 log MAR, ≥ 78 letters
• Interocular difference ≥ 3 log MAR lines (0.3 log MAR) or ≥ 15 letters
• No myopia greater than -6.00D spherical equivalent in either eye
• No planned strabismus surgery in the next 56 weeks
• No known allergy to adhesive patches or silicone

PEDIG X06

The primary objective of the study is to compare home versus office based visual acuity methods

• Age 3 to 17.5 years
• If the child wears contact lenses, the child must be able to perform all testing (in office and at home) in spectacle correction without contact lenses
• Have an iPhone 6 or a later version
• Be willing to return for a 3-month office visit
• Be able and willing to test VA at home 3 days after enrollment (Home test 1) and 1 day after home test 1 (Home test 2) and day before 3-month visit (Home Test 3)
• No use of atropine in the last 30 days, including the day of enrollment
• No use of atropine expected in the upcoming four months
• No dilation and cycloplegia within 48 hours of the first in-office VA measure

Protocol AM / DRCR

Randomized Trial Comparing Immediate versus Deferred Surgery for Symptomatic Epiretinal Membranes

• Age ≥50 years
• Vision better than 20/40
• Willing to wait for surgery
• No history of (DME), (RVO), or uveitis
• No retinal vascular disease, vitreous hemorrhage, retinal detachment, inflammatory disease, or associations other than vitreous syneresis, retinal break, or posterior vitreous detachment
• No known medical problems that will be a contraindication to surgery

Burgundy / Genentech / BP41670

A THREE-PART, PHASE I STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF ZIFIBANCIMIG FOLLOWING INTRAVITREAL ADMINISTRATION OF MULTIPLE ASCENDING DOSES AND CONTINUOUS DELIVERY FROM THE PORT DELIVERY IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION (BURGUNDY)

General Inclusion Criteria

• Willing to allow AH collection
• Age > 50 years, at the time of signing the informed consent

Study Eye Inclusion

• CNV exclusively due to AMD and with the following characteristics:
  • Active CNV lesions must be subfoveal or juxtafoveal with a subfoveal component related to CNV activity (e.g., subretinal fluid, intraretinal fluid, retinal pigment epithelium (RPE) detachment, etc.) at the time of screening (as assessed by the central reading center).
  • All subtypes of CNV are permissible
• Diagnosis of nAMD within nine months prior to the screening visit
• Previous treatment with at least two IVT anti-VEGF or anti-VEGF/Ang-2 administrations for nAMD per SoC within six months prior to the screening visit. The last IVT administration must have occurred at least 21 days prior to the screening visit
  • If a participant did not receive at least two IVT anti-VEGF or anti-VEGF/Ang-2 administrations as described above but is otherwise eligible for the study, the participant can be treated in a run-in period to meet this specific criterion
• Demonstrated response to prior IVT anti-VEGF or anti-VEGF/Ang-2 treatment since diagnosis, as evidenced at screening by the following:
  • Previous decrease in nAMD disease activity detected on SD-OCT, as assessed by the Investigator and confirmed by the central reading center AND
  • Previously stabilized or improved BCVA (as assessed by the Investigator)
• Availability of historical VA data prior to the first anti-VEGF or anti-VEGF/Ang-2 treatment for nAMD until the time of study enrollment
• Decreased BCVA attributable primarily to nAMD with letter score of 78 to 34 letters (inclusive) on ETDRS-like charts at screening. In case both eyes of a participant are eligible, the study eye selection is at the Investigator’s discretion

Exclusion Criteria Study Eye

• History of vitrectomy surgery, submacular surgery, other intraocular surgery, or any planned surgical intervention during the study period
• Cataract surgery without complications within three months preceding the screening visit or planned during the study period. Cataract surgery with complications falls under Exclusion Criterion 1.
• Prior macular treatment with verteporfin, external beam radiation therapy, transpupillary thermotherapy, or any type of laser photocoagulation
• Subretinal hemorrhage > 50% of the total lesion area and/or involving the fovea
• Retinal pigment epithelial tear involving the macula
• History of vitreous hemorrhage
• History of rhegmatogenous retinal detachment
• History of rhegmatogenous retinal tears or peripheral retinal breaks within three months prior to the screening visit
• Any concurrent intraocular conditions (e.g., cataract, diabetic retinopathy, epiretinal membrane with traction, macular hole) that, in the opinion of the Investigator, could either:
  • Require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition; or
  • Likely contribute to loss of BCVA over the study period if allowed to progress untreated; or
  • Preclude any visual improvement due to substantial structural damage
• Actual or history of myopia > -8 diopters
• Uncontrolled ocular hypertension or glaucoma (defined as IOP >25 mm Hg or a cup to disc ratio > 0.8, despite treatment with antiglaucoma medication) and any such condition the Investigator determines may require a glaucoma-filtering surgery during a participant’s participation in the study
• History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery
• History of corneal transplant
• Prior treatment with any medication for geographic atrophy.
• Prior treatment with any anti-VEGF-C or anti-VEGF-D inhibitors

Fellow Eye Exclusion

• BCVA letter score using ETDRS charts of < 34 letters
• Treatment with anti-VEGF or anti-VEGF/Ang-2 agents within one month prior to Day 1.

Either Eye Exclusion

• CNV due to causes other than nAMD, such as ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, uveitis or central serous chorioretinopathy
• Active intraocular inflammation (grade trace or above), infectious conjunctivitis, keratitis, scleritis, or endophthalmitis.
• History of uveitis, including history of any intraocular inflammation following IVT anti-VEGF or anti-VEGF/Ang-2 injections
• Prior treatment with brolucizumab         
• Prior gene therapy for nAMD

Concurrent Systemic Conditions Exclusions

• Uncontrolled blood pressure ([BP] defined as systolic > 180 mm Hg and/or diastolic > 100 mm Hg while participant at rest), at screening
• Uncontrolled atrial fibrillation within three months of screening
• History of myocardial infarction within last 12 months prior to screening
• History of stroke within last 12 months prior to screening
• Chronic use of oral corticosteroids (> 10 mg/day of prednisone or equivalent).
• Current systemic treatment for a confirmed active systemic infection
• Bleeding disorders, including platelet disorders, acquired or hereditary coagulations disorders, and acquired or hereditary vascular disorders
• Active malignancy within 12 months of screening except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score of < 6 and a stable prostate-specific antigen (PSA) for > 12 months
• Any major illness or surgical procedure within one month prior to screening
• Any febrile illness within one week prior to screening or Day 1
• History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a condition that contraindicates the use of the IMP or placement of the PD implant that might affect interpretation of the results of the study or renders the participant at high risk for treatment complications in the opinion of the Investigator

Ascent / REGENXBIO

A Randomized, Partially Masked, Controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants with nAMD

• Age ≥ 50 years and ≤ 89 years
• BCVA of 20/32 to 20/160
• CNV lesion size < 10-disc areas (typical disc area = 2.54 mm2)
• Received 10-12 anti-VEGF injection 12 months prior to Screening Visit 1
• Study eye with nAMD diagnosed > 4 years
• Pseudo phakic-at least 12 weeks post cataract surgery
• No central 1mm Subfoveal fibrosis or atrophy
• No chemotherapy and/or radiation in the 5 years prior to Screening Visit
• No heart attack, Stroke or TIA 6 months prior

Izokibep / Protocol 21103 / ACELYRIN

A Phase 2b Pivotal Study to Evaluate the Efficacy and Safety of Izokibep in Subjects with Non-infectious, Intermediate-, Posterior- or Pan-uveitis

• Subject must be ≥ 18 and ≤ 75 years of age
• Subject excluded with isolated anterior uveitis
• Malignancy within 5 years except treated/ cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, or in situ breast ductal carcinoma
• No severe PDR, significant DME/CME or Wet AMD
• Received ranibizumab/bevacizumab ≤ 73 days prior to 1st dose, aflibercept ≤ 88 days prior to 1st dose or brolucizumab 84 days from baseline or ≤ 112 days prior to 1st dose
• Patient likely requiring cataract surgery or planned (elective) eye surgery during the duration of the study

Meerkat / Protocol GR44277 / Genentech 

Double‑Masked, Sham‑Controlled Study to Investigate The Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of RO7200220 administered Intravitreally in Patients With Uveitic Macular Edema

• Age >18 years at the time of signing Informed Consent Form
• Diagnosis of macular edema associated with NIU defined as macular thickening by SD‑OCT involving the center of the macula as confirmed by the CRC: CST of >325 µm with Spectralis
• Diagnosis of active or inactive, acute, or chronic NIU of any etiology and of any anatomical type (anterior, intermediate, posterior, panuveitis).
• Vision of 20/40 – 20/400 Snellen
•  No blood transfusion within 12 months prior to screening
• No dexamethasone/betamethasone or equivalent subconjunctival steroid within 1 month prior to Day 1
• No methylprednisolone peri‑ocular injection (Depo‑Medrone) within 2 months prior to Day 1
• No dexamethasone (Ozurdex) 0.7 mg IVT implant within 4 months prior to Day 1
• No topical corticosteroids and/or topical NSAID > 3 drops per day in the 14 days prior to Day 1 (i.e., topical steroids and/or topical NSAIDs are permitted if the dose is up to 3 drops a day within 2 weeks prior to Day 1).

OPL-0401-201 / Valo Health

Evaluate the efficacy of OPL-0401 compared to placebo in improving diabetic retinopathy severity among patients with moderately severe to severe NPDR without DME, or with NPDR with DME and good VA

• Adults ≥ 18 years
• At least one eye w/ moderately severe to severe NPDR (DRSS levels 47 or 53)
• Patients with or without DME in either eye is eligible.
• If DME is present, DME must not have been previously treated and must not be expected to require treatment for DME during the duration of the study.
• No (VEGF) or any laser treatment is not required nor anticipated in either eye for least 6 months.
• No uncontrolled diabetes or patients who are not currently treated for their diabetes.
• No prior systemic anti-VEGF treatment in the 4 months prior to randomization
• No initiation of new antidiabetic medication, insulin, or insulin pump within 3 months prior to randomization, or planned treatment intensification for diabetes control,
• No history of cerebrovascular accident or myocardial infarction within 180 days prior to randomization 

iStar MINIject / iStar Medical / MINIject SO Integrated System CS627

A Prospective, multicenter masked clinical trial to evaluate the safety and effectiveness of the MINIject CS627 implant in subjects with open angle glaucoma

Major Inclusions:

• Males and females, 46 years of age or older
• A diagnosis of POAG, who are candidates for medical therapy, laser treatment, or glaucoma-filtering surgery, with optic nerve pathology described by one or more of the following:
  • Diffuse thinning, focal narrowing, or notching of the optic disc rim, especially at the inferior or superior poles with or without disc hemorrhage; or
  • Localized abnormalities of the peripapillary retinal nerve fiber layer, especially at the inferior or superior poles; or
• Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue
• A reliable Humphrey-Zeiss 24-2 SITA Standard or equivalent visual field for the study eye, defined as fixation losses, false positive, and false negative errors less than 33%
• Visual field defects consistent with glaucomatous optic nerve damage using Humphrey-Zeiss 24-2 SITA Standard or equivalent (conducted within 90 days of Screening is acceptable), with a mean deviation not worse than -12 dB; and at least one of the following two findings:
  • A cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is        depressed below the 1% level on the pattern deviation (PD) plot;
  • Glaucoma hemi-field test “outside normal limits”.
• Pseudophakic with prior uncomplicated cataract surgery ≥ 12 months prior to enrollment and with posterior chamber IOL in capsular bag
• Medicated IOP of ≤ 25 mmHg, or unmedicated IOP of ≥ 21 mmHg and ≤ 33 mmHg at the Screening Visit

Major Exclusions:

• Any diagnosis of glaucoma other than POAG, including, angle closure, congenital, or secondary glaucoma (e.g., pseudoexfoliative, pigmentary, neovascular, uveitic, traumatic, steroid induced, lens induced, malignant or glaucoma associated with increased episcleral venous pressure)
• Grade 2 (narrow, 20 degrees), grade 1 (extremely narrow, less or equal to 10 degrees) and grade 0 (closed or slit) according to Shaffer Angle Grading System
• Use of more than 4 classes of ocular hypotensive medications including each class of ocular hypotensive medication in combination medications. Each IOP-lowering drug in a combination medication will be recorded, reported and counted separately.
• Inability to perform Humphrey Visual Field (HVF) or equivalent perimetric testing in either eye
• Subjects with potential for significant risk by a washout of medication, including the following:
  • Subjects with potential for significant risk by a washout of medication, including the following:
    • On PD plot, greater than or equal to 75% of points depressed below the 5% level and greater than or equal to 50% of points depressed below 1% level; or
    • At least 50% of points (i.e., 2 or more) within central 5 degrees with sensitivity of < 0 dB on the dB plot; or
    • Points within the central 5 degrees of fixation with sensitivity < 15 dB in both hemifields on the dB plot
  • Subjects with fixation-threatening glaucoma in either eye noted at the qualifying visit, i.e., visual field defects threatening fixation defined as any (1 or more) point(s) within the central 5° depressed below the 5th percentile on PD plot unless this/these points are >25 dB on Threshold Values (decibel) plot.
• History of elevated IOP due to steroid response in the designated study eye
• BCDVA worse than 20/80 in either eye

COAST SLT study/ University of Pittsburg Collaborative study

A 48 month randomized clinical trial to compare the efficacy and safety of standard versus low energy primary SLT in eyes with OHT, mild-moderate POAG, and to determine the optimal interval and energy for repeat SLT (as needed at initially assigned energy versus annually at low energy)

Major Inclusions:

• Age 18 years or older
• Each eye with BCVA at least 20/200
• Both eyes with a qualifying diagnosis:
  • Ocular hypertension: IOP > 21 mmHg without glaucomatous optic neuropathy,
  • Early primary open-angle glaucoma: glaucomatous optic neuropathy, visual field mean deviation >-6.0 dB with no points in the central 5° 12 dB and no more than 1 central 5° point
  • Moderate primary open-angle glaucoma: glaucomatous optic neuropathy, visual field mean deviation -6.0 dB to >-12 dB and no more than 1 central 5° point

Major Exclusions:

• Severe POAG, pigmentary glaucoma, narrow angle glaucoma and all other types other than POAG.
• Mean IOP > 35 mmHg in either eye at the Eligibility or Baseline visit
• Contraindications to SLT, brimonidine, or any other study intervention
• Any intraocular surgical procedure within the past 6 months in either eye
• Pregnancy or planning to become pregnant in next four years

Pregonda / BP44175 / Genentech

A MULTI-CENTER, 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

Major Inclusions:

• Age 18 years or older, at the time of signing the informed consent.
• Diagnosis of Diabetes Mellitus  (Type 1 or Type 2), as defined by the World Health Organization and/or American Diabetes Association and
  • Current use of insulin or other injectable drugs (e.g., dulaglutide and liraglutide for the treatment of diabetes and/or
  • Current use of oral anti-hyperglycemic agents for the treatment of diabetes and/or
  • Dietary treatment as confirmed by qualified person.
• Macular thickening secondary to DME involving the center of the fovea with central subfield thickness (CST) ≥ 325 mm (Spectralis SD-OCT) at screening (Central Reading Center [CRC] confirmation required).
• Decreased best corrected visual acuity (BCVA) primarily due to DME with Early Treatment Diabetic Retinopathy Study (ETDRS) score of 78 to 19 letters (both inclusive) at screening

Major Exclusions:

• Any major illness or major surgical procedure ≤ 4 weeks before to Day 1 which in the opinion of the Investigator would affect the conduct or analysis of the study.
• Active cancer ≤ 1 year prior to Day 1.
• Renal failure
  • with renal transplant, or hemodialysis, or peritoneal dialysis ≤ 24 weeks prior to Day 1 and/or
  • anticipated to require hemodialysis or peritoneal dialysis at any time during the study
• Uncontrolled blood pressure, defined as systolic pressure >180 mmHg and/or diastolic BP >110 mmHg while a participant is at rest at Day 1
• Pre-treated participants can be enrolled, if none of the below exclusion criteria apply for the study eye.
  • IVT treatments with anti-VEGF component.
    • anti-VEGF treatment (e.g., Lucentis, Eylea [aflibercept 2 mg], Avastin) ≤ 8 weeks prior to Day 1
    • brolucizumab (Beovu) and faricimab (Vabysmo) treatment ≤ 16 weeks prior to Day 1
    • aflibercept 8 mg (Eyleaâ HD) treatment ≤ 24 weeks prior to Day 1
  • Periocular or intravitreal corticosteroid (e.g., triamcinolone acetonide [Triescence]) ≤ 16 weeks prior to Day 1.
  • Dexamethasone intravitreal implant (Ozurdex) ≤ 16 weeks prior to Day 1 
  • Fluocinolone acetonide intravitreal implant (YUTIQ, ILUVIEN or Retisert) ≤ 3 years prior to Day 1.
  • Topical steroids > 2 drops per day ≤ 7 days prior Day 1.
• Any active proliferative DR defined as:
  • Any neovascularization of the optic disc
  • Any neovascularization elsewhere
  • Any neovascularization of iris
  • Any neovascularization of irido-corneal angle
  • Vitreous or pre-retinal hemorrhage
  • Rhegmatogenous or tractional retinal detachment

• Any current or history of ocular disease other than DME that may confound the assessment of the macula or affect central vision per investigator’s best medical judgment, except for those instances where CRC confirmation is required, including but not restricted to:

  • Significant cataract
  • Epiretinal membrane that distorts the fovea (within central 1 mm ETDRS ring)
  • Central serous chorioretinopathy
  • Age-related macular degeneration (AMD; dry or wet) that would affect visual acuity or require treatment during the course of the study
  • Retinal vein occlusion
  • Infectious or noninfectious uveitis
  • Angioid streaks
  • Histoplasmosis
  • Active or inactive cytomegalovirus retinitis
  • Pathological myopia > -8 diopters
  • Retinal detachment
  • Vitreo-macular traction
  • Full thickness or lamellar macular hole
  • Peripapillary choroidal neovascularization or macular neovascularization
  • Optic atrophy or significant optic nerve pathology (e.g., glaucomatous excavation)
  • Any ocular condition that may:
    • Require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition
    • Contribute to worsening of BCVA over the study period
    • Preclude any visual improvement due to established structural damage
    • Lead to difficult interpretation of the study results

HONU / GE43220 / Genentech

A MULTICENTER, PROSPECTIVE, OBSERVATIONAL STUDY OF THE PROGRESSION OF INTERMEDIATE AGE-RELATED MACULAR DEGENERATION

• Age > 50 and < 95 years
• High-risk intermediate AMD with more than one large drusen >125 microns and AMD pigmentary abnormalities
• No evidence of nGA, cRORA, or GA secondary to AMD
• No Concurrent or Hx of PRP or anti-VEGF treatment for exudative MNV, DME, RVO, or PDR in study eye
• No PDR or Moderate/Severe NPDR
• No previous participation in interventional clinical trials for GA or early stages of AMD, except for vitamins and minerals,) within the last 6 months
• No active cancer requiring treatment

 Parasol / Protocol 81201887MDG2001 / Janssen

A Phase 2b, Randomized, Double-masked, Multicenter, Dose-ranging, Sham-controlled Clinical Trial to
Evaluate Intravitreal JNJ-81201887(AAVCAGsCD59) Compared to Sham Procedure for the Treatment
of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)

• 60 years of age or older
• Have non-subfoveal (defined as not involving the center point of the fovea) GA secondary to AMD with an area measuring 2.5 mm to 17.5 mm (1 and 7 disc areas respectively), determined by the CRC from screening images of FAF and SD-OCT
• If GA is multifocal, at least one focal lesion must be ≥1.25 mm (0.5 disc area)
• Vision better than 20/100 in the study eye
• Fellow eye must be present with a BCVA of counting fingers or better
• No exudative AMD in either eye or history of exudative AMD
• No presence of macular fibrosis or retinal epithelial tear, clinically relevant myopic degeneration, or vitreous hemorrhage,
  • Benign conditions of the vitreous (ie, posterior vitreous detachment) or peripheral retina (ie, paving stone degeneration, lattice degeneration, etc.) are permitted.
• Uncontrolled glaucoma (defined as IOP >22 despite treatment with more than 2 anti-glaucoma medications) or advanced glaucoma (cup to disc ratio >0.8).
• No previous intravitreal drug delivery, implant, anti-complement agents, or device implantation
  • A single intra or perioperative administration of a corticosteroid during cataract surgery for cystoid macular edema prophylaxis at least 6 months prior to enrollment is permitted