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Lack of eligible subjects.
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Anti-VEGF therapy has been proven efficacious for the wet (neovascular) form of macular degeneration and may be beneficial for the treatment of choroidal neovascularization (CNV) due to other causes. The limitation of this type of treatment is the necessity for frequent intraocular injections. The purpose of this study is to determine if using anti-VEGF therapy in combination with photodynamic therapy can reduce the number of treatments needed with monotherapy while achieving similar visual results. There are ongoing multicenter trials evaluating combination therapy in patients with wet AMD but no similar trial for patients with CNV due to non-AMD causes. Therefore, in this study the investigators will focus on patients with CNV not due to AMD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monotherapy | Active Comparator | Bevacizumab (Avastin; Genentech, Inc.)1.25 mg by intravitreal injection on day 0 and then prn (as-needed) based on ophthalmic examination and OCT findings |
|
| Combination therapy | Active Comparator | Intravitreal injection of bevacizumab 1.25 mg (Avastin; Genentech, Inc.) combined with reduced fluence PDT(Visudyne®; Novartis,) and 200 ug of intravitreal dexamethasone(4mg/ml, American regent, Inc) on Day 0 and then monthly retreatment with bevacizumab as-needed and triple therapy every 3 months as-needed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab (Avastin; Genentech, Inc.) | Drug | 1.25 mg bevacizumab (Avastin; Genentech, Inc.) by intravitreal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean number of treatments per group | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in visual acuity from baseline | Mean change in visual acuity from baseline
|
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Inclusion Criteria:
Only one eye will be assessed in the study. If both eyes are eligible, the investigator and patient will determine which eye is to be treated, considering such factors as disease duration, and likelihood of response to treatment.
Exclusion Criteria:
Pregnancy or lactation
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| Name | Affiliation | Role |
|---|---|---|
| Ivana K Kim, MD | Massachussetts Eye& Ear Infirmary | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40522203 | Derived | Lange CA, Qureshi R, Pauleikhoff L. Interventions for central serous chorioretinopathy: a network meta-analysis. Cochrane Database Syst Rev. 2025 Jun 16;6(6):CD011841. doi: 10.1002/14651858.CD011841.pub3. |
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| Bevacizumab, Dexamethasone, Verteporfin Photodynamic Therapy | Drug | Intravitreal injection of 1.25 mg bevacizumab (Avastin; Genentech, Inc.) combined with reduced-fluence verteporfin PDT (Visudyne®; Novartis) and 200ug of intravitreal dexamethasone |
|
| 12 months |
| ID | Term |
|---|---|
| D020256 | Choroidal Neovascularization |
| D009216 | Myopia |
| D000080363 | White Dot Syndromes |
| D000080364 | Multifocal Choroiditis |
| D056833 | Central Serous Chorioretinopathy |
| D000793 | Angioid Streaks |
| D014947 | Wounds and Injuries |
| D015785 | Eye Diseases, Hereditary |
| ID | Term |
|---|---|
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012030 | Refractive Errors |
| D015866 | Uveitis, Posterior |
| D015864 | Panuveitis |
| D014605 | Uveitis |
| D002833 | Choroiditis |
| D012164 | Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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