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Infliximab, Sirolimus and Daclizumab to Treat Age-Related Macular Degeneration (AMDB1)

Primary Purpose

Age-Related Macular Degeneration, Choroidal Neovascularization

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Intravenous Daclizumab
Intravenous Infliximab
Observation
Oral Rapamycin
Sponsored by
National Eye Institute (NEI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-Related Macular Degeneration focused on measuring Age-Related Macular Degeneration, Rapamycin, Remicade, Daclizumab, Immunosuppression, Infliximab, Choroidal Neovascularization, Sirolimus, AMD, Ocular Inflammation

Eligibility Criteria

55 Years - 92 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA: Understand and sign the institutional review board (IRB)-approved informed consent document for the study. Age greater than 55 years. In the study eye, diagnosis of AMD defined by the presence of drusen larger than 63 microns. Any anti-angiogenic therapy in the study eye within 7 days of beginning immunosuppressive therapy. In the study eye, the participant's study eye vision is between 20/20 and 20/400. In the study eye, the presence of CNV under the fovea determined by the investigators and defined as any one of the following fluorescein angiographic (FA) features: Early stippled hyperfluorescence of flat retinal pigment epithelium (RPE)and little or mild leakage in the late frames of the fluorescein (occult). Irregular elevation of the RPE that does not exhibit discrete or bright hyperfluorescence in the early transit phase of the angiogram. Stippled hyperfluorescence may be present. Late frames may show persistent fluorescein staining or leakage within a sensory retinal detachment overlying this area (occult). Late-phase leakage of undetermined source with leakage at the level of the RPE in the late-phase frames of the angiogram in which the source of the late leakage cannot be determined from earlier-phase frames of the angiogram (occult). A well-demarcated area of bright hyperfluorescence in the early phase of the angiogram with leakage through the mid- and late-phase frames which obscures the boundaries of the area (classic). For all CNV lesions considered to have occult CNV with no classic CNV, one of the following criteria must be met: A documented loss of visual acuity (5 or more letters of best-corrected visual acuity if both measurements are made using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart or, a doubling of the visual angle if Snellen acuities are available from either an outside referral center or within the participating center (e.g., 20/80 to 20/160) a doubling of the visual angle is required because of the measurement variability of Snellen acuities). OR Documented FA evidence of a 10% increase in the lesion greatest linear dimension over the 3 months prior to enrollment. OR Documented blood associated with CNV. The greatest linear dimension of the entire lesion (classic CNV, occult CNV and any features that could obscure the identification of classic or occult CNV) has to be less than or equal to 5400 microns in greatest linear dimension on the retina as measured by the treating ophthalmologist. Retinal photographs and angiography of sufficient quality, allowing assessment of the macular area according to standard clinical practice, can be obtained. Women of childbearing potential must not be pregnant or lactating, must have a negative pregnancy test at screening and must be practicing an adequate method of birth control. Acceptable methods of birth control include intrauterine device (IUD); oral, dermal, implanted or injected contraceptives; tubal ligation; and barrier methods with spermicide. Willingness to comply with the protocol. EXCLUSION CRITERIA: CNV, 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. Evidence of retinal angiomatous proliferation as suspected by the presence of intraretinal hemorrhage, intraretinal leakage, adjoining serous pigment epithelial detachment (PED) or the presence of a connecting retinal vessel. The presence of a chorio-retinal anastomosis. Decreased vision, in the study eye, due to retinal disease not attributable to CNV, such as nonexudative forms of AMD, geographic atrophy, inherited retinal dystrophy, uveitis or epiretinal membrane. Participants who have any additional ocular diseases that have irreversibly compromised or, during follow-up, could likely compromise the visual acuity (VA) of the study eye including amblyopia, anterior ischemic optic neuropathy, clinically significant diabetic macular edema, severe non-proliferative diabetic retinopathy, or proliferative diabetic retinopathy. Decreased vision, in the study eye, due to significant media opacity such as corneal disease or cataract, or opacity precluding photography of the retina; a tear (rip) of the RPE; a vitelliform-like lesion of the outer retina (e.g., as in pattern dystrophies or basal laminar drusen), idiopathic parafoveal telangiectasis, or central serous retinopathy. Presence of fibrosis, hemorrhage, pigment epithelial detachments and other hypofluorescent lesions obscuring greater than 50% of the CNV lesion. History of other systemic antiangiogenic treatment or treatment for CNV (not including photodynamic therapy and pegaptanib sodium injections) in the study eye with transpupillary thermotherapy or other local treatment (such as submacular surgery). Previous laser photocoagulation therapy is acceptable, provided it was not subfoveal. Participant with a known underlying systemic disease with evidence of serious or potentially lethal uncontrolled active disease in one or more extraocular organ systems for which a defined effective medical regimen is indicated. Participant with a corneal melting, necrotizing keratitis, or impending vision loss. Participants with history of allergy to/or exposure to mouse protein. Participant with scleritis of infectious etiology. Participant receiving any other investigational therapy or another anti-tumor necrosis factor (TNF) agent that would interfere with the ability to evaluate the safety or efficacy of infliximab. Participant has significant active infection requiring hospitalization. Participant with multiple sclerosis. Participant has severe (class 3/4) congestive heart failure. Participant has a history of cancer within the past 5 years other than basal or squamous cell carcinoma. Participant is pregnant or lactating. Participant with posterior scleritis. Participant has evidence of liver disease (any etiology). History of moderate to severe abnormal liver function, unless documented evidence of normal liver enzymes is provided. Participant has positive PPD (tuberculosis test) unless cleared by Internal Medicine. Participant has positive Chest X-ray showing acute pulmonary disease. Participant has unexplained hematuria. Participant has a history of alkylating therapy use. Current exam evidence of ocular toxoplasmosis; pseudoexfoliation; external ocular infection, including conjunctivitis; chalazion; significant blepharitis; or aphakia in the study eye (pseudophakic participants are eligible). Intraocular surgery (including lens replacement surgery) within 6 weeks prior to randomization. Recent history of (within the last 6 months), or current acute ocular or periocular infection (including any history of ocular herpes zoster or simplex). Known hypersensitivity/allergy to verteporfin, porfimer sodium, or other porphyrins, porphyria or other porphyrin sensitivity, or hypersensitivity to sunlight or bright artificial light. Participation in any other clinical study or are receiving, or have received any experimental systemic treatment for AMD (e.g., retinoic acid, thalidomide). Local therapy for AMD is permitted. Medical problems that make consistent follow-up over the treatment period unlikely (e.g., stroke, severe myocardial infarction (MI), end stage malignancy), any contraindications to performing the necessary diagnostic studies (i.e., known allergy to fluorescein dyes etc.), or in general a poor medical risk because of other systemic diseases or active uncontrolled infections. Participant has a history of moderate to severe abnormal liver function, unless documented evidence of normal liver enzymes is provided. Participant has a history of active pulmonary tuberculosis. Participant has a history of active viral hepatitis. Participant has chronic continued Ketoconazole use.

Sites / Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Other

Arm Label

Intravenous Daclizumab

Intravenous Infliximab

Oral Rapamycin

Observation

Arm Description

Participants randomly assigned to intravenous (IV) daclizumab received 8 mg/kg of IV daclizumab at baseline, then 4 mg/kg of IV daclizumab at Week 2 and then 2 mg/kg of IV daclizumab monthly for the rest of the 6-month study.

Participants randomized to IV infliximab received 3 mg/kg of IV infliximab monthly for 6 months.

Participants randomly assigned to rapamycin received 2 mg in capsule form every other day for 6 months.

Participants randomly assigned to the observation group were given injections of either bevacizumab (1.25 mg/0.05 mL or 2.5 mg/0.1 mL) or ranibizumab (0.5 mg) if they presented with recurrence of intraretinal or subretinal fluid as seen on Stratus Optical Coherence Tomography.

Outcomes

Primary Outcome Measures

Monthly Rates of Anti-VEGF (Vascular Endothelial Growth Factor) Injections

Secondary Outcome Measures

Changes in Best-corrected Visual Acuity (BCVA) as Measured by the Standard Early Treatment Diabetic Retinopathy Study (ETDRS) Protocol From Baseline to 24 Weeks
The values in the table represent the denominator for the visual acuity in feet. A value of 20 represents "normal" 20/20 vision while increasing values for the denominator represent worsening vision.
Changes in Retinal Thickness as Measured by Optical Coherence Tomography (OCT) From Baseline to 24 Weeks

Full Information

First Posted
March 17, 2006
Last Updated
November 28, 2016
Sponsor
National Eye Institute (NEI)
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1. Study Identification

Unique Protocol Identification Number
NCT00304954
Brief Title
Infliximab, Sirolimus and Daclizumab to Treat Age-Related Macular Degeneration
Acronym
AMDB1
Official Title
Treatment of Choroidal Subretinal Neovascularization With Agents Directed Against the Immune Response
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Eye Institute (NEI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study examined whether the anti-inflammatory medicines infliximab, sirolimus or daclizumab, when given with a participant's current therapies, would prevent the growth of new blood vessels in the eye in participants with age-related macular degeneration (AMD). Participants 55 years of age and older with AMD and drusen larger than 63um may be eligible for this study. Vision in the study eye was between 20/20 and 20/400. Participants were randomly assigned to one of three treatments - infliximab, sirolimus, or daclizumab - or to observation only. In addition, participants may have been treated by their ophthalmologist as needed for their AMD. Infliximab and daclizumab were given intravenously (through a vein); infusions were given at enrollment in the study, then at 2 weeks, and then monthly. Sirolimus was a pill that was taken every other day for the duration of the study. At 6 months, participants were evaluated to see whether continuing treatment would be beneficial. In addition to treatment or observation, participants underwent the following procedures: Physical examination at enrollment and 6 months. Photographs of the back of the eye, fluorescein angiography, indocyanine green angiography and measurement of retinal thickness at enrollment and months 1, 3 and 6. Fluorescein angiography evaluated the eye's blood vessels. A yellow dye was injected into an arm vein and traveled to the blood vessels in the eyes. Pictures of the retina were taken using a camera that flashed a blue light into the eye. The pictures show if any dye has leaked from the vessels into the retina, indicating possible blood vessel abnormality. Indocyanine green angiography identified feeder vessels that may have supplied abnormal blood vessels. This procedure is similar to fluorescein angiography, but uses a green dye and flashes an invisible light. Optical coherence tomography measures retinal thickness. This test shines a light into the eye and produces cross-sectional pictures of the retina. These measurements are repeated during the study to determine whether retinal thickening is getting better or worse, or staying the same. Tuberculin skin test and chest x-ray at enrollment and 6 months. Blood tests at enrollment and months 1, 3 and 6.
Detailed Description
There has been much interest in the possible role of the immune system in AMD. Experimental models and patient material have, to date, suggested a role for macrophages and complement. This study hypothesized that the underlying mechanism that leads to choroidal neovascularization (CNV) is similar to those at play in atherosclerosis. If this is the case, the investigators believed that CNV treatment should be amenable to new immunomodulatory agents directed against specific parts of the immune system. After therapy with anti-angiogenic agents not leading to a persistent remission of CNV due to AMD, participants were treated with one of three immunomodulatory agents or were observed in conjunction with their continued anti-angiogenic therapy. Thus the participant continued with the anti-angiogenic therapy they received after randomization. The investigators hypothesized that this combination therapy would inhibit progression of CNV associated with AMD. This was an open-label, phase II, randomized, single center clinical trial of 18 study participants randomized to receive one of three immunomodulatory agents or was observed in conjunction with their anti-angiogenic therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration, Choroidal Neovascularization
Keywords
Age-Related Macular Degeneration, Rapamycin, Remicade, Daclizumab, Immunosuppression, Infliximab, Choroidal Neovascularization, Sirolimus, AMD, Ocular Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravenous Daclizumab
Arm Type
Active Comparator
Arm Description
Participants randomly assigned to intravenous (IV) daclizumab received 8 mg/kg of IV daclizumab at baseline, then 4 mg/kg of IV daclizumab at Week 2 and then 2 mg/kg of IV daclizumab monthly for the rest of the 6-month study.
Arm Title
Intravenous Infliximab
Arm Type
Active Comparator
Arm Description
Participants randomized to IV infliximab received 3 mg/kg of IV infliximab monthly for 6 months.
Arm Title
Oral Rapamycin
Arm Type
Active Comparator
Arm Description
Participants randomly assigned to rapamycin received 2 mg in capsule form every other day for 6 months.
Arm Title
Observation
Arm Type
Other
Arm Description
Participants randomly assigned to the observation group were given injections of either bevacizumab (1.25 mg/0.05 mL or 2.5 mg/0.1 mL) or ranibizumab (0.5 mg) if they presented with recurrence of intraretinal or subretinal fluid as seen on Stratus Optical Coherence Tomography.
Intervention Type
Drug
Intervention Name(s)
Intravenous Daclizumab
Other Intervention Name(s)
Zenapax
Intervention Description
Participants randomly assigned to intravenous (IV) daclizumab received 8 mg/kg of IV daclizumab at baseline, then 4 mg/kg of IV daclizumab at Week 2 and then 2 mg/kg of IV daclizumab monthly for the rest of the 6-month study.
Intervention Type
Drug
Intervention Name(s)
Intravenous Infliximab
Other Intervention Name(s)
Remicade
Intervention Description
Participants randomized to IV infliximab received 3 mg/kg of IV infliximab monthly for 6 months.
Intervention Type
Other
Intervention Name(s)
Observation
Intervention Description
Participants randomly assigned to the observation group were given injections of either bevacizumab (1.25 mg/0.05 mL or 2.5 mg/0.1 mL) or ranibizumab (0.5 mg) if they presented with recurrence of intraretinal or subretinal fluid as seen on Stratus Optical Coherence Tomography.
Intervention Type
Drug
Intervention Name(s)
Oral Rapamycin
Other Intervention Name(s)
Sirolimus
Intervention Description
Participants randomly assigned to rapamycin received 2 mg in capsule form every other day for 6 months.
Primary Outcome Measure Information:
Title
Monthly Rates of Anti-VEGF (Vascular Endothelial Growth Factor) Injections
Time Frame
24 Weeks
Secondary Outcome Measure Information:
Title
Changes in Best-corrected Visual Acuity (BCVA) as Measured by the Standard Early Treatment Diabetic Retinopathy Study (ETDRS) Protocol From Baseline to 24 Weeks
Description
The values in the table represent the denominator for the visual acuity in feet. A value of 20 represents "normal" 20/20 vision while increasing values for the denominator represent worsening vision.
Time Frame
Baseline and 6 months (24 weeks) - Baseline and 3.5 months for Patient 7
Title
Changes in Retinal Thickness as Measured by Optical Coherence Tomography (OCT) From Baseline to 24 Weeks
Time Frame
Baseline and 6 months (24 weeks) - Baseline and 3.5 months for Patient 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
92 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA: Understand and sign the institutional review board (IRB)-approved informed consent document for the study. Age greater than 55 years. In the study eye, diagnosis of AMD defined by the presence of drusen larger than 63 microns. Any anti-angiogenic therapy in the study eye within 7 days of beginning immunosuppressive therapy. In the study eye, the participant's study eye vision is between 20/20 and 20/400. In the study eye, the presence of CNV under the fovea determined by the investigators and defined as any one of the following fluorescein angiographic (FA) features: Early stippled hyperfluorescence of flat retinal pigment epithelium (RPE)and little or mild leakage in the late frames of the fluorescein (occult). Irregular elevation of the RPE that does not exhibit discrete or bright hyperfluorescence in the early transit phase of the angiogram. Stippled hyperfluorescence may be present. Late frames may show persistent fluorescein staining or leakage within a sensory retinal detachment overlying this area (occult). Late-phase leakage of undetermined source with leakage at the level of the RPE in the late-phase frames of the angiogram in which the source of the late leakage cannot be determined from earlier-phase frames of the angiogram (occult). A well-demarcated area of bright hyperfluorescence in the early phase of the angiogram with leakage through the mid- and late-phase frames which obscures the boundaries of the area (classic). For all CNV lesions considered to have occult CNV with no classic CNV, one of the following criteria must be met: A documented loss of visual acuity (5 or more letters of best-corrected visual acuity if both measurements are made using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart or, a doubling of the visual angle if Snellen acuities are available from either an outside referral center or within the participating center (e.g., 20/80 to 20/160) a doubling of the visual angle is required because of the measurement variability of Snellen acuities). OR Documented FA evidence of a 10% increase in the lesion greatest linear dimension over the 3 months prior to enrollment. OR Documented blood associated with CNV. The greatest linear dimension of the entire lesion (classic CNV, occult CNV and any features that could obscure the identification of classic or occult CNV) has to be less than or equal to 5400 microns in greatest linear dimension on the retina as measured by the treating ophthalmologist. Retinal photographs and angiography of sufficient quality, allowing assessment of the macular area according to standard clinical practice, can be obtained. Women of childbearing potential must not be pregnant or lactating, must have a negative pregnancy test at screening and must be practicing an adequate method of birth control. Acceptable methods of birth control include intrauterine device (IUD); oral, dermal, implanted or injected contraceptives; tubal ligation; and barrier methods with spermicide. Willingness to comply with the protocol. EXCLUSION CRITERIA: CNV, 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. Evidence of retinal angiomatous proliferation as suspected by the presence of intraretinal hemorrhage, intraretinal leakage, adjoining serous pigment epithelial detachment (PED) or the presence of a connecting retinal vessel. The presence of a chorio-retinal anastomosis. Decreased vision, in the study eye, due to retinal disease not attributable to CNV, such as nonexudative forms of AMD, geographic atrophy, inherited retinal dystrophy, uveitis or epiretinal membrane. Participants who have any additional ocular diseases that have irreversibly compromised or, during follow-up, could likely compromise the visual acuity (VA) of the study eye including amblyopia, anterior ischemic optic neuropathy, clinically significant diabetic macular edema, severe non-proliferative diabetic retinopathy, or proliferative diabetic retinopathy. Decreased vision, in the study eye, due to significant media opacity such as corneal disease or cataract, or opacity precluding photography of the retina; a tear (rip) of the RPE; a vitelliform-like lesion of the outer retina (e.g., as in pattern dystrophies or basal laminar drusen), idiopathic parafoveal telangiectasis, or central serous retinopathy. Presence of fibrosis, hemorrhage, pigment epithelial detachments and other hypofluorescent lesions obscuring greater than 50% of the CNV lesion. History of other systemic antiangiogenic treatment or treatment for CNV (not including photodynamic therapy and pegaptanib sodium injections) in the study eye with transpupillary thermotherapy or other local treatment (such as submacular surgery). Previous laser photocoagulation therapy is acceptable, provided it was not subfoveal. Participant with a known underlying systemic disease with evidence of serious or potentially lethal uncontrolled active disease in one or more extraocular organ systems for which a defined effective medical regimen is indicated. Participant with a corneal melting, necrotizing keratitis, or impending vision loss. Participants with history of allergy to/or exposure to mouse protein. Participant with scleritis of infectious etiology. Participant receiving any other investigational therapy or another anti-tumor necrosis factor (TNF) agent that would interfere with the ability to evaluate the safety or efficacy of infliximab. Participant has significant active infection requiring hospitalization. Participant with multiple sclerosis. Participant has severe (class 3/4) congestive heart failure. Participant has a history of cancer within the past 5 years other than basal or squamous cell carcinoma. Participant is pregnant or lactating. Participant with posterior scleritis. Participant has evidence of liver disease (any etiology). History of moderate to severe abnormal liver function, unless documented evidence of normal liver enzymes is provided. Participant has positive PPD (tuberculosis test) unless cleared by Internal Medicine. Participant has positive Chest X-ray showing acute pulmonary disease. Participant has unexplained hematuria. Participant has a history of alkylating therapy use. Current exam evidence of ocular toxoplasmosis; pseudoexfoliation; external ocular infection, including conjunctivitis; chalazion; significant blepharitis; or aphakia in the study eye (pseudophakic participants are eligible). Intraocular surgery (including lens replacement surgery) within 6 weeks prior to randomization. Recent history of (within the last 6 months), or current acute ocular or periocular infection (including any history of ocular herpes zoster or simplex). Known hypersensitivity/allergy to verteporfin, porfimer sodium, or other porphyrins, porphyria or other porphyrin sensitivity, or hypersensitivity to sunlight or bright artificial light. Participation in any other clinical study or are receiving, or have received any experimental systemic treatment for AMD (e.g., retinoic acid, thalidomide). Local therapy for AMD is permitted. Medical problems that make consistent follow-up over the treatment period unlikely (e.g., stroke, severe myocardial infarction (MI), end stage malignancy), any contraindications to performing the necessary diagnostic studies (i.e., known allergy to fluorescein dyes etc.), or in general a poor medical risk because of other systemic diseases or active uncontrolled infections. Participant has a history of moderate to severe abnormal liver function, unless documented evidence of normal liver enzymes is provided. Participant has a history of active pulmonary tuberculosis. Participant has a history of active viral hepatitis. Participant has chronic continued Ketoconazole use.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Nussenblatt, MD, MPH
Organizational Affiliation
National Eye Institute (NEI)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12428187
Citation
Aeberli D, Oertle S, Mauron H, Reichenbach S, Jordi B, Villiger PM. Inhibition of the TNF-pathway: use of infliximab and etanercept as remission-inducing agents in cases of therapy-resistant chronic inflammatory disorders. Swiss Med Wkly. 2002 Jul 27;132(29-30):414-22. doi: 10.4414/smw.2002.10031.
Results Reference
background
PubMed Identifier
12382299
Citation
Antoni C, Dechant C, Hanns-Martin Lorenz PD, Wendler J, Ogilvie A, Lueftl M, Kalden-Nemeth D, Kalden JR, Manger B. Open-label study of infliximab treatment for psoriatic arthritis: clinical and magnetic resonance imaging measurements of reduction of inflammation. Arthritis Rheum. 2002 Oct 15;47(5):506-12. doi: 10.1002/art.10671.
Results Reference
background
PubMed Identifier
10372996
Citation
Bian ZM, Elner SG, Strieter RM, Kunkel SL, Lukacs NW, Elner VM. IL-4 potentiates IL-1beta- and TNF-alpha-stimulated IL-8 and MCP-1 protein production in human retinal pigment epithelial cells. Curr Eye Res. 1999 May;18(5):349-57. doi: 10.1076/ceyr.18.5.349.5353.
Results Reference
background
PubMed Identifier
20847709
Citation
Nussenblatt RB, Byrnes G, Sen HN, Yeh S, Faia L, Meyerle C, Wroblewski K, Li Z, Liu B, Chew E, Sherry PR, Friedman P, Gill F, Ferris F 3rd. A randomized pilot study of systemic immunosuppression in the treatment of age-related macular degeneration with choroidal neovascularization. Retina. 2010 Nov-Dec;30(10):1579-87. doi: 10.1097/IAE.0b013e3181e7978e.
Results Reference
result

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Infliximab, Sirolimus and Daclizumab to Treat Age-Related Macular Degeneration

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