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 or older;
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
►Study:
Anecortave Risk-Reduction Trial (AART)
Sponsor: Alcon Laboratories, Inc.
Status: Enrolling patients
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: 24
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
►A
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
►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 mm; 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 greater than 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:
SIRNA 0401
Sponsor: Sirna Therapeutics, Inc., Boulder, Colo
Status: Enrolling patients
Purpose: Assess the safety and tolerability of
Sirna-027; assess the presence of Sirna-027 in plasma; determine the range of
doses for the phase 2 clinical trial; and assess biological and anatomical
changes in the retina
Design: Phase 1, open-label, dose-escalation: 4
to 6 dose cohorts, 1 intravitreal injection
Number of Patients: 12�30
Site(s): 4�Wilmer Eye Institute, Baltimore, Md;
Massachusetts Eye and Ear Infirmary, Boston, Mass; Cole Eye Institute, Cleveland
Clinic Foundation, Cleveland, Ohio, Jules Stein Eye Institute, UCLA, Los
Angeles, Calif
Inclusion/Exclusion Criteria: 50 years of age or
older; subfoveal to AMD, classic and/or occult; no other causes of CNV; total
lesion size 12 MPS disc area; subretinal hemorrhage <50% of lesion; subfoveal
scarring <50% of lesion; lesion thickness 250 μm; IOP 25 mm Hg; visual acuity
20/100 to 20/800 ETDRS; fellow eye visual acuity not worse than 20/800 ETDRS
Information: (720) 406-2963
►Study:
Visudyne with Intravitreal Triamcinolone Acetonide (VisTA) Trial
Sponsor: LuEsther T. Mertz
Retinal Research
Center
Status: Recruiting
Purpose: Evaluate the effect of photodynamic
therapy 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:
Safety and Efficacy of AG-013958 in Subjects with Subfoveal CNV Associated with
Age-related Macular Degeneration
Sponsor: Pfizer
Status: Recruiting
Purpose: Assess the safety, efficacy, and
pharmacokinetics of the investigational drug AG-013958 in subjects with
exudative AMD
Design: Phase 1/2, randomized, masked, single and
multiple-dose, single and multiple-dose, sequential dose-escalation
Inclusion Criteria: �55 years of age; AMD,
minimally classic & occult-classic eligible in stage 2 of study (after first 46
pts); no subfoveal fibrosis; total lesion fibrosis or scar <25% total area;
hemorrhage <50% of total lesion area; total lesion area �9 DA; ETDRS best
corrected score of approximately 20/40-20/230; fellow eye VA �24 letters (20/320
or better); normal ECG or nonsignificant changes
Exclusion Criteria: Prior PDT <3 months before
entry; serous pigment epithelial detachment without surrounding
neovascularization; diabetic retinopathy, glaucoma, or other serious ocular
diseases or conditions; prior subfoveal photocoagulation of the macula; prior
intravitreal, sub-Tenon's, or systemic therapy for AMD; prior TTT (transpupillary
thermotherapy) or intravitreal steroids in study eye or likely to undergo these
procedures within 6 months of entry; cataract surgery within previous 12 months;
intraocular surgery within previous 3 months; prior vitrectomy or submacular
surgery; prior scleral buckling, myopia �6 D; sitting BP >159/99 mm Hg on 2 out
of 3 evaluations; stroke within the previous 12 months; h/o severe cardiac
disease; peripheral vascular disease; unstable angina; MI within 6 months;
ventricular tachycardia requiring treatment; inability to stop anticoagulants 4
days prior to injection (ASA okay to continue); participation in any clinical
trials within the previous
60 days; use of systemic steroids currently or
within the previous 30 days
Information: Retina Associates of Cleveland,
(216) 831-5700
►Study:
AdGVPEDF.11D in Neovascular Age-Related Macular Degeneration (Wet AMD)
Sponsor: GenVec, Inc.
Status: Part 1 is complete; Part 2 is enrolling
patients
Purpose: To assess the safety, tolerability and
feasibility of single direct intravitreal injection of AdPEDF, identify an
appropriate dose range for phase 2 testing of AdPEDF and assess the biologic
activity of AdPEDF.
Design: Phase 1, open-label, dose-escalating
study of a single intravitreal administration of AdPEDF. Part 1 of the study is
complete; AdPEDF (at 8 ascending dose levels) was administered to 28 patients
with severe wet AMD and was generally well-tolerated at all dose levels, with no
dose-limiting toxicities, endophthalmitis, retinal or vitreous detachment,
cataracts or glaucoma. Part 2 will treat 20 additional patients with less
advanced (moderate to severe) wet AMD at 2 of the highest doses tested in part 1
Inclusion Criteria: Patients of at least 50 years
in age, with moderate to severe wet AMD (best corrected vision of 20/40 to
20/320 in the most impaired eye); active leakage or CNV with lesion diameter
less than or equal to 5400 μm and no significant subretinal fluid, who are not
candidates for, or who have refused treatment with, subfoveal laser
photocoagulation or PDT
Exclusion Criteria: Significant retinal disease
other than neovascular AMD; significant non-retinal disease; cataract or other
significant media opacity; other causes of choroidal neovascularization such as
pathologic myopia (>8 D), ocular histoplasmosis or angioid streaks; evidence of
inflammation (grade 1 or higher) in the anterior and/or posterior chambers;
cataract surgery or submacular surgery within 3 months; prior ocular treatment
with radiation; known allergy to fluorescein; liver enzymes >2 x ULN (ALT, AST,
bilirubin); clinical evidence of active infection of any type, including
adenovirus, hepatitis A, B, or C virus or HIV virus; other treatment for AMD in
the study eye within the last 12 weeks prior to Day 1; other experimental
medications within the last 4 weeks prior to Day 1; abnormal prothrombin or
partial thromboplastin time (>1.5 x ULN) or anticoagulant therapy that cannot be
withheld for treatment; prior or current glaucoma or any atrophic change in the
fovea
Number of Patients: Up to 48
Number of Site(s): Seven (7)- Wilmer Eye
Institute, Baltimore, Md, Jules Stein Eye Research Center, Los Angeles, Calif,
Kresge Eye Institute, Detroit, Mich, Casey Eye Institute, Portland, Ore,
University of Washington, Seattle, Wash, Cullen Eye Institute/McPherson,
Houston, Texas, Florida Eye Microsurgical Institute, Inc., Boynton Beach, Fla
Information: (240)
632-5591,
rdibartolomeo@genvec.com,
www.genvec.com
►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), choroidal
neovascularization (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:
A Phase 2 Evaluation of Anti-VEGF Therapy for Diabetic Macular Edema:
Bevacizumab (Avastin)
Sponsor: National Eye Institute
Number of patients: 100
Status: Recruiting
Purpose: To provide preliminary data on the dose
and dose-interval related effects of intravitreally administered Avastin on
retinal thickness and visual acuity in subjects with DME to aid in planning a
phase 3 trial; to provide preliminary data on the safety of intravitreally
administered Avastin in subjects with DME
Design: Randomized, single-blind
Inclusion Criteria: �18 years;
type 1 or 2 diabetes mellitus; BCVA �24 and �78; definite retinal thickening due
to central DME; OCT central subfield �275 μm
Information: Ingrid U. Scott, MD
E-mail:
iscott@psu.edu
►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 optical
coherence tomography (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 non-proliferative 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 diabetic macular edema; 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 myopic macular degeneration
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 in this
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
COMPLETED TRIALS
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
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
A
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: July 2006