Macugen Observational Study

Macugen monotherapy: referred to participants receiving Macugen in the study eye during the study that is (i.e.) participants without any concomitant drug treatment or nondrug treatment for the study eye during the study. Combination therapy: referred to participants receiving combination therapy in the study eye (during the study) i.e. participants with any concomitant drug treatment or nondrug treatment for the study eye during the study.

OCT, a noninvasive, noncontact, transpupillary imaging technology, was utilized to image retinal structures in vivo with a resolution of 10 to 17 microns. The anatomic layers within the retina, retinal thickness could be measured. Improvement in OCT parameters was defined as a reduction of more than or equal to 100 microns in the central macular thickness (Center subfield).

A fluorescein angiogram provides information about the condition of the retina. Improvement in FFA parameters was defined as absence of progression of the lesion or decrease in the size of the lesion and absence of new lesions on FFA i.e. change in lesion size from baseline must be less than or equal to 0 disc area(DA) and no new lesions.

Early lesions were defined by any 2 of the following criteria: occult lesion diagnosed on FFA; baseline VA of more than or equal to 54 ETDRS letters; lesion size of less than 2DA on FFA. Stabilization of VA was defined as loss of less than 15 letters in the BCVA. Improvement in the VA was defined as gain of more than or equal to 15 letters in the BCVA.

Stabilization of VA was defined as loss of less than 15 letters in the BCVA. For each participant, number of injections before reaching the first "stabilization in VA" (considered as an event) was counted. For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up.

Stabilization of VA was defined as loss of less than 15 letters in the BCVA. Median number of injections to achieve stabilization of VA in participants with early lesions was estimated via the Kaplan Meier method. For each participant, number of injections before reaching the first "stabilization in VA" (considered as an event) was counted. For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up.

FFA was utilized to characterize the lesions as follows: Classic lesion: more than 50% of the lesion had a well-demarcated area of hyperfluorescence; minimally classic lesion: less than or equal to 50% of lesion had well-demarcated area of hyperfluorescence; occult lesion: lesion with no well demarcated borders. VA statuses were defined as: stabilization: loss of less than 15 letters in the BCVA; improvement: gain of more than or equal to 15 letters in the BCVA.

Participants were considered treatment naive when started on Macugen and without any previous drug or non drug treatment administered to the study eye. Participants were considered previously treated by any other therapy if received any other drug or non drug treatment to the study eye except Macugen.

VA was measured using ETDRS chart at 4 meter distance, at 1 meter distance (if patient's VA was poor) or verifying if the patient was able only to count fingers, to perceive hand motion or light. VA was measured as the number of ETDRS letters correctly read. VA statuses were defined as: stabilization: loss of less than 15 letters in the BCVA; improvement: gain of more than 15 letters in the BCVA.

OCT, a noninvasive, noncontact, transpupillary imaging technology, was utilized to image retinal structures in vivo with a resolution of 10 to 17 microns. The anatomic layers within the retina, retinal thickness could be measured. Improvement in OCT parameters was defined as a reduction of more than or equal to 100 microns in the central macular thickness (Center subfield). Improvement in OCT parameters was measured based on this single parameter.

OCT, a noninvasive, noncontact, transpupillary imaging technology, was utilized to image retinal structures in vivo with a resolution of 10 to 17 microns. The anatomic layers within the retina, retinal thickness could be measured. Improvement in OCT parameters was defined as a reduction of more than or equal to 100 microns in the central macular thickness (Center subfield). Improvement in OCT parameters was measured based on this single parameter.