CLINICAL
TRIAL UPDATE
DRY
AMD
►Study: Age-Related Eye Disease
Study II (AREDS II)
Sponsor: National Eye Institute
Status: Enrolling patients as of May/June 2006
Purpose: Investigate the effects of oral supplements of lutein/zeaxanthin
and omega-3 fatty acids for the treatment of AMD. A secondary randomization will
further refine the AREDS-type supplement by testing lower dose of zinc and eliminating
beta-carotene
Design: Phase 3, randomized, prospective, multicenter trial
Number of Patients: 4000
Number of Clinical Centers: 80 plus
Inclusion Criteria: Age greater than or equal to 55 years to 80
years; bilateral large drusen (>125 μm)
or advanced AMD (neovascular AMD or geographic atrophy involving the center of fovea)
in 1 eye only and presence of large drusen in the fellow eye
Exclusion Criteria: Choroidal neovascularization associated with
other ocular diseases such as pathologic myopia, ocular histoplasmosis or posterior
uveitis, other confounding ocular disease or surgical procedures (except for cataract
surgery or YAG laser)
Information:
http://www.nei.nih.gov/neitrials/viewStudyWeb.aspx?id=120
►Study:
OT-551
Sponsor: National Eye Institute
Status: Enrolling patients
Purpose: To investigate whether the topically applied antioxidant
OT-551 can help slow progression of atrophic "dry" AMD
Inclusion criteria: Age �50
years; geographic atrophy or the dry form of AMD in both eyes; no history of neovascular
or "wet form" of AMD in either eye; have not participated in any other AMD clinical
trial except using vitamins; no previous ocular surgery other than cataract surgery;
not presently receiving chemotherapy; must be medically stable and able to complete
the study; participation requires 7 visits over approximately 2 years, with
vision testing and eye exams at each visit
Information: Ruby Lerner, RN
Phone: (301) 451-3437
Fax: (301) 480-2566
E-mail: lernerru@nei.nih.gov
A Study: Anecortave Risk-Reduction
Trial (AART)
Sponsor: Alcon Laboratories, Inc.
Status: Enrollment complete
Purpose: A 48-month study of posterior juxtascleral administrations
of anecortave acetate 15 mg, 30 mg, or sham administrations every 6 months
Design: Randomized, double-blind
Number of Patients: 2500
Inclusion Criteria: Age >50 years; dry AMD in study eye, wet
AMD in non-study eye
Information: Alcon; (817)568-6747
E-mail:
inteldev@alconlabs.com
►Study: CNTF Implants for People with Vision
Impairment Due to Atrophic AMD
Sponsor: National Eye Institute
Status: Enrolling Patients
Purpose: To investigate the effects of CNTF implants in patients
with vision impairment due to atrophic AMD
Inclusion criteria: BCVA in the study eye <20/63–20/160
(58 to >39 letter score) as measured EVA; Presence in the study and/or fellow
eye of angiographic atrophy (GA)
Exclusion Criteria: Less than 50 years of age; medically unable
to comply with study tests or follow-up visits; evidence of ocular disease other
than AMD (eg, diabetic retinopathy, central serous chorio-retinopathy, uveitis,
pathologic myopia, glaucoma); evidence of and history of treatment for CNV other
than antioxidant vitamins and minerals; previous intraocular surgery except for
cataract surgery; participation in any other clinical trial for AMD (except for
vitamin therapy); inability to obtain quality fundus photographs; history of ocular
herpes simplex virus
Information: Renee Gaiter, RN, BSN
Phone: (301) 594-9825
Fax: (301) 435-1629
E-mail:
gaiter@nei.nih.gov
►Study:
NT-501
Sponsor: Neurotech
Status: Enrolling patients
Purpose: To evaluate the efficacy and safety of the CNTF implant
Design: Phase 2, randomized, double-masked, sham-controlled, dose-ranging
study
Site(s): 1
Information: (212) 213-0006
WET
AMD
►Study: Safety and Efficacy of Repeated
Intravitreal Administration of VEGF Trap in Patients with Wet AMD
Sponsor: Regeneron Pharmaceuticals
Status: Enrolling patients
Purpose: To assess the ocular and systemic safety and tolerability
of repeated intravitreal doses of VEGF Trap in patients with subfoveal CNV due to
AMD
Design: Phase 2, randomized, double-blind, dose comparison, parallel
assignment, safety/efficacy
Number of Patients: 150
Inclusion Criteria: Age >50 years; subfoveal CNV secondary
to AMD; central retinal (including lesion) thickness �300
μm as measured by OCT; ETDRS BCVA
of 73-34 letters
Exclusion Criteria: History of any vitreous hemorrhage within
4 weeks prior to day 1; aphakia; significant subfoveal atrophy or scarring; prior
treatment with the following in the study eye: subfoveal thermal laser therapy;
submacular surgery or other surgical intervention for the treatment of AMD; extrafoveal
laser coagulation treatment within 12 weeks prior to day 1; PDT within
12 weeks prior to visit 2 (day 1); pegaptanib sodium within 8 weeks of visit
2 (day 1); juxtascleral steroids or anecortave acetate within 24 weeks (6 months)
prior to visit 2 (day 1); intravitreal administration of triamcinolone acetonide
or other steroids within 24 weeks prior to visit 2 (day 1) unless no visible residue
of drug substance can be seen in the vitreous cavity using indirect ophthalmoscopy;
prior systemic or intravitreal treatment with VEGF Trap, ranibizumab, or bevacizumab
Information: Regeneron
E-mail:
VEGF.Trap@regeneron.com
►Study: Infliximab, Sirolimus, and Declizumab
to Treat AMD
Sponsor:
National Eye Institute
Status: Enrolling patients
Purpose: To examine whether anti-inflammatory medicines infliximab,
sirolimus, or declizumab, when given with a patient's current therapies, will prevent
the growth of new blood vessels in the eye in patients with AMD
Design: Phase 2, open-label, randomized, single center
Number of Patients: 20
Inclusion Criteria: Age >55 years; AMD with drusen �63
μm; any antiangiogenic therapy
in study eye within 7 days of beginning study treatment; vision 20/40-20/400 in
study eye; CNV under fovea, as defined by FA features detailed in study criteria;
occult CNV with no classic to meet study criteria
Exclusion Criteria: CNV in the study eye associated with other
ocular diseases such as pathologic myopia, ocular histoplasmosis or posterior uveitis;
presence of geographic atrophy under the fovea in the study eye; evidence of retinal
angiomatous proliferation as suspected by the presence of intraretinal hemorrhage,
intraretinal leakage, adjoining serous PED or the presence of a connecting
retinal vessel; presence of chorioretinal anastomosis; decrease in vision due to
retinal disease not attributable to CNV or significant media opacity; presence of
fibrosis, hemorrhage, pigment epithelial detachments or other hypofluorescent lesions
obscuring >50% of CNV lesion; history of other antiangiogenic treatment or treatment
of CNV (not including PDT and pegaptanib sodium) in study eye with TTT or other
local treatment; please see complete trial information for additional exclusion
criteria
Information: National Eye Institute
E-mail:
prpl@mail.cc.nih.gov
►Study: ADVANCE: Study of Vatalanib and
Photodynamic Therapy with Verteporfin in Patients with Subfoveal CNV Secondary to
AMD
Sponsor: Novartis
Status: Enrolling patients
Purpose: To test the safety of vatalanib in combination with verteporfin
in patients with CNV forming beneath the macula due to AMD
Design: Phase 1/2, randomized, double-blind
Inclusion Criteria: Age >65 years; wet AMD; size of lesion
must be �5400 μm;
if minimally classic type or occult only type, lesion must be �6
disc areas and must have recent disease progression; 20/40-20/320
Exclusion Criteria: Prior treatment in study eye for CNV; uncontrolled
high blood pressure, despite chronic stable treatment; systolic �140
mm Hg, diastolic �90 mm Hg; history
of ECG abnormalities
Information:
http://clinicaltrials.gov/ct/show/NCT00138632?order=39
►Study: A Study to Evaluate Ranibizumab
in Subjects with CNV Secondary to AMD (SAILOR)
Sponsor: Genentech
Status: Enrolling patients
Purpose: (Primary) To estimate the incidence of ocular and non-ocular
serious adverse events in subjects treated with intravitreal ranibizumab; (Secondary)
To estimate the incidence of ocular and non-ocular adverse events and the proportion
of subjects with a decrease from baseline in BCVA of at least 15 letters at month
12
Design: Phase 3b, single-masked multicenter, randomized
Number of Patients: 5000
Inclusion Criteria: Age >50 years; signed consent form; subfoveal
CNV secondary to AMD, with evidence of recent disease progression, as defined by
any of the following: �5 letters of
BCVA lost within 6 months preceding day 0; �10%
increase in lesion area, as determined by FA performed within 1 month preceding
day 0 to FA performed within 6 months preceding day 0; classic CNV compromising
>50% of CNV lesion area; BCVA using EDTRS charts for Cohort 1 and Snellen charts
for Cohort 2, of 20/40-20/320 in the study eye
Exclusion Criteria: Treatment with verteporfin PDT, pegaptanib
sodium, or other AMD therapy in the study eye <30 days preceding day 0; history
of submacular surgery or other surgical intervention for AMD in study eye;
previous participation in any studies of investigational drugs within 30 days preceding
day 0 (excluding vitamins and minerals); prior participation in a Genentech ranibizumab
clinical trial; treatment with intravitreally administered Avastin within 30 days
preceding day 0; concurrent use of systemic anti-VEGF drugs; fibrosis or atrophy
involving the center of the fovea in the study eye, in the absence of a new lesion;
CNV in either eye due to other causes, such as ocular histoplasmosis, trauma,
or pathologic myopia; RPE tear involving the macula in the study eye; any concurrent
intraocular condition, active intraocular inflammation or current VH in the study
eye; history of rhegmatogenous retinal detachment or macular hole (stage 3 or 4)
in study eye; history of idiopathic or autoimmune-associated uveitis in either eye;
active infectious keratitis, scleritis, or endophthalmitis in either eye; aphakia
or pseudophakia with absence of the posterior capsule; spherical equivalent of the
refractive error in study eye demonstrating within 2 months preceding day 0; uncontrolled
glaucoma in study eye; concurrent use of more than 1 therapy for glaucoma; glaucoma
filtering surgery or corneal transplant in study eye; history of other disease,
metabolic dysfunction, physical examination finding, or clinical lab finding to
contraindicate the use of an investigational drug that might affect interpretation
of the results or render the subject at high risk for treatment complications; current
treatment for significant active systemic infection; evidence of significant uncontrolled
concomitant diseases such as cardiovascular disease, nervous system, pulmonary,
renal, hepatic, endocrine, or gastrointestinal disorders; history of recurrent significant
infections or bacterial infections; inability to comply with study or follow-up
procedures
Information: (888) 662-6728
►Study: A
Clinical Trial to Explore the Safety and Efficacy of 3 Different Doses of Pegaptanib
Sodium in Patients with Wet AMD
Sponsor: (OSI) Eyetech/Pfizer
Status: Recruiting
Purpose: To
compare the ability of 3 different doses of pegaptanib sodium to safely and
effectively minimize fluid leakage within the eye, thereby stabilizing or improving
vision in patients with wet AMD; the study will also examine the effects of pegaptanib
sodium on the cornea and sensory retina of patients with wet AMD
Design: Phase 4, randomized, double-blind
Number of Patients: 262
Inclusion Criteria: Age >50 years; subfoveal CNV due to AMD;
BCVA in the study eye between 20/40-20/320; normal electroretinogram and corneal
endothelial cell density of 1500 cells/mm2 or
more
Exclusion Criteria: Any prior PDT with Visudyne or thermal laser
to the study eye
Information: (866) 622-8436
►Study: Macugen
Alone, vs Macugen in Combination with PDT with Visudyne in Patients with AMD
Sponsor: (OSI) Eyetech/Pfizer
Status: Recruiting
Purpose: To compare whether Macugen in combination with PDT with
Visudyne is safe and effective in slowing the leakage of fluid within the eye and
thereby stabilizing or improving vision when compared to Macugen alone
Design: Phase 3b/4, randomized, double-blind
Number of Patients: 360
Inclusion Criteria: Age >50 years; subfoveal CNV due to AMD
with predominantly classic lesion composition; BCVA in the study eye between 20/40-20/200
Exclusion Criteria: Any prior PDT with Visudyne or AMD thermal
laser to the study eye
Information: (866) 622-8436
►Study: MRVT-920101-OPH005
Sponsor: Miravant Pharmaceuticals, Inc.
Status: Recruiting
Purpose: Confirm the efficacy and safety of rostaporfin (PHOTREX)
photodynamic therapy in the treatment of classic and occult subfoveal choroidal
neovascularization associated with AMD
Design: Multi-centered, multinational, randomized, double-masked,
placebo-controlled, phase 3
Number of Patients: 660
Site(s): Multiple European Union and non-European locations
Inclusion Criteria: Age >50 years; at least 1 subfoveal CNV
membrane secondary to AMD that can be demonstrated by fluorescein angiography; best
corrected VA score of 20/40–20/200
Information: (800) 685-2959
►Study:
Visudyne with Intravitreal Triamcinolone Acetonide (VisTA) Trial
Sponsor: LuEsther T. Mertz
Retinal Research Center
Status: Recruiting
Purpose: Evaluate the effect of PDT in conjunction with intravitreous
triamcinolone acetonide in subjects with occult or minimally classic subfoveal CNV
secondary to AMD
Design: Randomization 1:1:1, PDT and 0 mg of triamcinolone/PDT
and 1 mg of triamcinolone/PDT and 4 mg of triamcinolone
Inclusion Criteria: Age >50 years; occult or minimally classic
subfoveal CNV, presence of blood associated with the lesion, vision loss or growth
of lesion objectively recorded within preceding 3 months; baseline VA score
between 20/40–20/400, lesion �5400 μm
Exclusion Criteria: Predominantly classic CNV, additional eye
disease, CNV not involving geometric center of FAZ, inability to be photographed;
fluorescein allergy; photophobia; lens opacities expected to progress during study;
previous treatment for CNV, other than confluent laser photocoagulation (eg, PDT,
submacular surgery, radiotherapy, macular grid); participation in another clinical
trial; IOP >21 mm Hg on or off meds; prior treatment with another antiangiogenic
compound within 6 months of screening; inability to comply with all study-related
procedures; concomitant therapy with systemic or topical corticosteroids or NSAIDs
(chronic concomitant therapy is defined as multiple doses taken daily for 3 or more
consecutive days at any time during the course of the 12-month study); a low dose
of ASA (up to 100 mg PO qd) taken for prophylaxis of MI and/or stroke is permitted
during the study; concomitant coumadin therapy
Number of Patients: 120
Information: Namrata Saroj, (202) 605-3777
►Study:
Preservative-free Triamcinolone
Acetonide (PFTA)
Sponsor: QLT Inc., National Eye Institute
Status: Enrolling patients
Purpose: Investigate the long-term safety and potential efficacy
of PFTA in patients with wet AMD (all types) undergoing Visudyne therapy
Design: Phase 3, randomized, prospective
Number of Patients: 300
Inclusion Criteria: Age greater than or equal to 50 years; in
the study eye, diagnosis of AMD defined by the presence of drusen larger than 63 μm; visual acuity of 20/40 - 20/200
(73-34 letter score) as measured on an ETDRS chart; in the study eye, the presence
of choroidal neovascularization under the fovea
Exclusion Criteria: Choroidal neovascularization, in the study
eye, associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis
or posterior uveitis, etc.; presence of geographic atrophy under the fovea in the
study eye; the presence of a chorio-retinal anastomosis; presence of fibrosis, hemorrhage,
pigment epithelial detachments, and other hypofluorescent lesions obscuring greater
than 50% of the CNV lesion
Information: (301) 496-5248
►Study:
Squalamine
Sponsor: Genaera Corporation
Status: Enrolling patients
Purpose: Evaluate the safety and efficacy of intravenously administered
squalamine as a first-line therapy for wet AMD
Design: Phase 2, randomized, double-masked, controlled study;
2 dose levels once weekly for 4 weeks, followed by maintenance doses once every
4 weeks through week 48; at the end of therapy, each patient will be followed for
an additional year
Number
of Patients: 100
Site(s): Multicenter
Information: (610) 941-4020
►Study:
Interval Dose Evaluation of Anecortave Acetate (IDEAA)
Sponsor: Alcon
Status: Recruiting
Purpose: Compare anecortave acetate
15 mg administered every 3 months vs anecortave acetate 15 mg
administered every 6 months vs anecortave acetate
30 mg administered every 6 months in patients with exudative AMD
Design: Prospective, randomized 1:1:1
Inclusion Criteria: Clinical diagnosis of exudative AMD and a
primary or recurrent (after laser photocoagulation) subfoveal CNV lesion, lesion
area �12 disc areas; (30.5 mm) of any lesion type (predominantly classic, minimally
classic, or occult), CNV �50% of the total lesion progression for occult lesions
(defined as having experienced a loss of at least 1 line of vision or change in
lesion size of more than 1 disc area [2.54 mm] or the appearance of new blood in
the lesion within the past
3 months); snellen equivalent of 20/40 to 20/200
visual acuity in the study eye (no vision criteria for the non-study eye).
Exclusion Criteria: Amblyopia; uncontrolled glaucoma with
an IOP >30 mm Hg; ischemic optic neuropathy; PDR, clinically relevant NPDR;
clinically relevant diabetic macular edema; significant active uveitis; clinical
signs of myopic retinopathy, or refraction of �8 D in the patient's current Rx;
more than 1 PDT treatment
in the study eye; extrafoveal or juxtafoveal thermal
laser treatment less than 30 days prior to enrollment, more than 2 Macugen injections
in the study eye; more than 1 triamcinolone treatment in the study eye; previous
treatment with anecortave acetate in the study eye; intraocular surgery in the study
eye within 60 days prior to enrollment; scleral buckle in the study eye; any previous
systemic antiangiogenic therapy for AMD; radiation treatment in the study eye; scleral
thinning; any unstable medical condition that would preclude ability to keep study
visits; coumadin therapy that cannot be interrupted for a 5-day period
Information: Alcon, (866) 692-5959
►Study:
Genetic Factors in AMD
Sponsor: National Eye Institute
Status: Enrolling patients
Purpose: To examine whether certain polymorphisms predispose people
to develop AMD.
Design: Screening
Number of Patients: 400
Inclusion Criteria: (AMD patients) Age �50 years; diagnosis
of advanced AMD defined by geographic atrophy and/or CNV with drusen of any size
in at least
1 eye; (Control patients) Age >70 years; absence of drusen or
no more than 5 drusen <63 μm;
absence of other diagnostic criteria for AMD
Exclusion Criteria: Presence of retinal disease involving the
photoreceptors and/or outer retinal layers other than AMD loss such as high
myopia, retinal dystrophies, central serous retinopathy, vein occlusion, diabetic
retinopathy and uveitis or similar outer retinal diseases that have been present
prior to the age of 50; opacities of the ocular media; limitations of papillary
dilation or other problems sufficient to preclude adequate stereo fundus photography
(occluded pupils due to synechia, cataracts, vitreous haze, and opacities due
to ocular diseases
Information: (800) 411-1222
DIABETIC
MACULAR EDEMA
►Study:
Effect of Ruboxistaurin on Clinically Significant Macular Edema
Sponsor: Eli Lilly and Company
Number of patients: 220
Status: Recruiting
Purpose: To test the hypothesis that oral administration of ruboxistaurin
for approximately 18 months will reduce baseline to endpoint changes in macular
thickness, as measured by OCT in patients with clinically significant macular edema
Design: Randomized, double-blind, placebo control
Inclusion Criteria: �18 years; type 1 or
2 diabetes; HbA1c �11%;
mild to severe non-proliferative diabetic retinopathy in study eye; clinically significant
macular edema in study eye
Exclusion Criteria: Previous surgery or laser treatment (or need
for laser treatment within 3 months) in study eye; glaucoma in study eye; unstable
cardiovascular disease; major surgery within past 3 months; significantly impaired
kidney or liver function, or malignancy requiring chemotherapy or radiation
therapy
Information: (877)285-4559
►Study:
Evaluation of Vitrectomy for DME
Sponsor: Diabetic Retinopathy Clinical Research Network
Number of sites: 29
Number of patients: approximately 400
Status: Recruiting
Purpose: To provide information on the following outcomes in eyes
with DME that undergo vitrectomy: visual acuity, retinal thickening, resolution
of traction (if present), surgical complications; to identify subgroups in which
there appears to be a benefit of vitrectomy and subgroups in which vitrectomy does
not appear to be beneficial; to obtain data that can be used to plan a randomized
trial
Design: The study is designed as a prospective cohort study. A
cohort study provides the opportunity to collect data prospectively using a standardized
protocol to assess the potential benefits and risks of vitrectomy. The results can
be used to determine whether proceeding with a randomized trial has merit and what
the design of the trial should be. If a randomized trial is to be conducted, the
results plus the cohort study experience can be used to help design the RCT protocol.
Inclusion/Exclusion Criteria: Age �18 years old, study eye with
vitrectomy being performed as treatment of DME, study eye with best corrected visual
acuity 20/800 or better (E-ETDRS visual acuity score �3 letters)
Information:
http://public.drcr.net/studies/ProtocolD_vitrectomy/ProtDInfo.html
►Study:
An Observational Study of the Development of DME Following Scatter Laser Photocoagulation
Sponsor: Diabetic Retinopathy Clinical Research Network
Number of sites: 18
Number of patients: approximately 150
Status: Recruiting
Purpose: To determine the incidence and extent of macular edema
following scatter laser photocoagulation surgery using OCT in eyes without macular
edema prior to scatter laser photocoagulation, and to explore whether the incidence
and extent of macular edema varies according to the number of sittings included
in the treatment regimen
Design: Prospective, multi-center, nonrandomized clinical trial
Inclusion/Exclusion Criteria: Age �18 years, study eye with (1)
OCT center point thickness �200 μm
and (2) early proliferative or severe nonproliferative diabetic retinopathy for
which investigator intends to perform full scatter photocoagulation in either 1
sitting or 4 sittings
Information:
http://public.drcr.net/studies/ProtocolF_prp/ProtFInfo.html
►Study:
Subclinical DME Study
Sponsor: Diabetic Retinopathy Clinical Research Network
Number of sites: 18
Number of patients: Approximately 1000 patients will be enrolled
in order to follow 220 patients
Status: Recruiting
Purpose: To determine how often study participants' eyes with
subclinical DME (defined as no edema involving the center of the fovea as determined
by biomicroscopy but with center point thickness on OCT of at least 200 μm
but less than or equal to 299 μm)
progress over a 2-year period to edema on OCT of at least 300 μm
(which is almost always clinically apparent) and increase at least 50 μm
from baseline or are treated for DME among individuals with more than minimal
retinopathy (greater than level 20), and to determine mean OCT retinal thickness
measurements and confidence intervals in subjects with diabetes and no or
minimal nonproliferative
diabetic retinopathy (level 20 or less)
Design: Prospective, multi-center, observational study. The study
consists of a baseline phase and follow-up phase
Inclusion/Exclusion Criteria: Age �18 years, study eye with best
corrected E-ETDRS acuity �74 letters (20/32 or better)
Information:
http://public.drcr.net/studies/ProtocolG_subclinical/ProtGInfo.html
►Study:
FAME (Fluocinolone Acetonide in Macular Edema)
Sponsor: Alimera Sciences & Controlled Delivery Systems
Number of Sites: Approximately 100
Number of Patients: over 900
Status: Phase 3 initiated
Purpose: To evaluate the safety and efficacy of sustained-release
fluocinolone acetonide, at 2 doses, delivered via the Medidur intraocular sustained
delivery system
Design: Double-masked, randomized, multi-center, parallel group,
controlled study
Inclusion/exclusion Criteria: Patients diagnosed with DME, who
have
previously had laser treatment
Information:
www.alimerasciences.com
►Study:
Reduction in the Occurrence of Center-threatening DME
Sponsor: Eli Lilly and Company
Status: Recruiting
Purpose: Determine whether ruboxistaurin can slow the progression
of DME
Design: Randomization 1:1, ruboxistaurin/ placebo
Inclusion Criteria: Type 1 or type 2 diabetes; >18 years; non-clinically
significant DME; mild to moderate diabetic retinopathy in the study eye or vitreous
hemorrhage in the study eye; relatively good vision (20/30 or better)
Exclusion Criteria: Surgery or laser treatment in the study eye;
glaucoma in the study eye; HbA1c >11%, or systolic blood pressure <170 mm
Hg
Information: (877) 285-4559
►Study:
IVTA and Laser Photocoagulation for DME
Sponsor: Diabetic Retinopathy Clinical Research Network
Status: Recruiting
Sites: 98
Purpose: Determine whether IVTA at doses of 1 mg or 4 mg provides
greater benefit, with an acceptable safety profile, than macular laser in the treatment
of DME
Design: 1 eye eligible: randomization, 1:1:1, laser/1 mg triamcinolone/4
mg triamcinolone. Both eyes eligible: 1 eye randomized to laser, the other to 1
mg or
4 mg of triamcinolone
Inclusion/Exclusion Criteria: Age �18 years, study eye with best
corrected E-ETDRS acuity >24 letters (20/320 or better) and <68 letters (worse
than 20/40), study eye with center-involved DME present on clinical exam and on
OCT, mean retinal thickness on 2 OCT measurements >250 μm
in the central subfield, fellow eye either eligible or has acuity >19 letters
(20/400 or better) has not been previously treated with intravitreal corticosteroids
Number of Patients: 795
Site(s): 98
Information:
http://public.drcr.net/studies/ProtocolB_steroid/ProtBInfo.html
►Study:
Macugen in Diabetic Macular Edema and Diabetic Retinopathy
Sponsor: (OSI) Eyetech
Status: Enrolling
Purpose: To compare the safety and efficacy of Macugen in patients
with DME
Design: Phase 3, randomized, controlled, double-masked, multi-center,
comparative, dose finding
Number of Patients: Planned enrollment is 900
Site(s): 41
Information: 212-824-3100
MYOPIC
MACULAR DEGENERATION
►Study:
Study to Evaluate the Safety and Efficacy of Combretastatin A4 Phosphate for Treating
Subfoveal Choroidal Neovascularization in Subjects with Pathologic Myopia
Sponsor: OXiGENE, Inc.
Status: Recruiting
Purpose: Myopic macular degeneration (MMD) is a progressive eye
disease caused by thinning of the retina and underlying support tissue as the eye
is stretched and elongated. The purpose of this study is to evaluate the safety
and dose response of Combretastatin A4 Phosphate (CA4P), an investigational drug,
in patients with active choroidal neovascularization secondary to MMD
Design: This phase 2 clinical trial is an open label, dose-ranging,
international, multicentered study. Drug is administered intravenously
Number of Patients: 36
Sites: 15
Inclusion Criteria: 18–50 years of age, patients must have
pathologic myopia presenting refractive error of -6 D or more correction required
OR an axial length of the eye >26.5 mm, area of choroidal neovascularization
within 50 μm or under the geometric
center of the foveal-avascular zone, BCVA in the study eye of 20/20 to 20/200, inclusive
in the qualifying eye (by ETDRS measurement)
Exclusion Criteria: Patients must not be currently pregnant, planning
a pregnancy, patients must not have received any previous experimental procedure
in either eye or have used any investigational drug or treatment within 30 days
prior to enrolling inthis trial
Information:
www.oxigene.com
CENTRAL RETINAL VEIN OCCLUSION
►Study:
The Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study
Sponsor: National Eye Institute, National Institutes of Health,
Department of Health and Human Services
Status: Enrollment began in October 2004
Purpose: To compare the effectiveness and safety of standard care
to intravitreal injection(s) of triamcinolone for treating macular edema (swelling
of the central part of the retina) associated with CRVO and BRVO
Design: Multicenter, randomized, phase 3 trial. Eligible patients
within each of these 2 disease entities are randomized in a 1:1:1 ratio to 1 of
3 groups: standard care, intravitreal injection(s) of 4 mg of triamcinolone acetonide,
or intravitreal injection(s) of 1 mg of triamcinolone acetonide. Enrolled patients
are followed for 3 years. The preparation of triamcinolone acetonide used in the
study is specially made for injection into the eye and does not contain any preservatives
Inclusion/Exclusion Criteria: Participants with macular edema
associated with CRVO and BRVO who are 18 years of age or older and are willing
to provide consent. Detailed Inclusion/Exclusion Criteria are available on the SCORE
Web site at
http://spitfire.emmes.com/study/score
Number of Patients: 1260; 630 with CRVO and 630 with BRVO
Site(s): 27
Information: (301) 251-1161
WET AMD
►Study:
MSI-1256F-209
Sponsor: Genaera Corporation
Number of Patients: 40
Sites: 1
Information: (610) 941-4020
Results: Available at
www.genaera.com/pressreleases/2003_Oct7.html
►Study:
Combretastatin A-4 Phosphate (CA4P) in Patients with Neovascular AMD (FBO-206)
Sponsor: OXiGENE
Number of Patients: 15–20
Site(s): 1, Wilmer Eye Institute, Baltimore, Md
Information: (781) 547-5912
Results: Available at
www.oxigene.com
►Study:
ANCHOR
Sponsor: Genentech
Number of Patients: 423
Site(s): 100
Information: (888) 662-6728
Results: 1-year results available at:
www.gene.com
►Study:
MARINA
Sponsor: Genentech
Number of Patients: 716
Site(s): 100
Information: (888) 662-6728
Results: Available at:
www.gene.com
►Study:
Evaluation and Tolerability of 4-dose Levels of Cand5 Administered by Single
Intravitreal Injection in Patients with Wet AMD
Sponsor: Acuity Pharmaceuticals
Number of Patients: 15
Site(s): 2
Information: (215) 966-6191
Results:
www.acuitypharm.com
►Study:
PIER
Sponsor: Genentech
Number of patients: 184
Site(s): 3
Information: For inquiries about clinical trials, please submit
a request through our information request form or call (888) 662-6728. For international
inquiries, contact our international collaborator, Novartis Ophthalmics, at
(866) 393-6336; www.novartisophthalmics.com
Results: Available at: www.gene.com
►Study:
SIRNA 0401
Sponsor: Sirna Therapeutics, Inc., Boulder, Colo
Number of Patients: 12–30
Information: (720) 406-2963
Results: Available at:
www.sirna.com
DIABETIC
MACULAR EDEMA
►Study:
EOP-1005
Sponsor: (OSI) Eyetech and Pfizer Inc.
Number of Patients: 169 (included in safety population); 172 (randomized)
Site(s): 41
Information: (212) 824-3100
Results: Published in the October issue of Ophthalmology
►Study:
Laser Photocoagulation for DME
Sponsor: Diabetic Retinopathy Clinical Research Network (DRCR.net)
Number of Patients: 263
Site(s): 78
Information:
http://public.drcr.net/studies/ProtocolA_laser/ProtAInfo.html
Results: Not currently available
Retinal Physician, Issue: September 2006